Clinical trial NCT02473913
Conditions: Trichotillomania Hair Pulling Disorder
Sponsor: University of Chicago
Start date: 2015-03-01; Completion date: 2020-09-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk thistle) in children and adults with trichotillomania. The hypothesis to be tested is that silymarin will be more effective and well tolerated in children and adults with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Detailed description:
Pathological hair-pulling, trichotillomania, has been defined as repetitive, intentionally performed pulling that causes noticeable hair loss and results in clinically significant distress or functional impairment. Trichotillomania appears relatively common with an estimated prevalence between 1-3%. Data on the pharmacological treatment of trichotillomania is limited to case reports and conflicting double-blind studies of serotonin reuptake inhibitors. One positive double-blind study of N-acetyl cysteine in adults was not successful when examined for children and adolescents. Available data on the treatment of trichotillomania in children are therefore limited.

Silymarin, a flavonoid and a member of the Asteraceae family, is extracted from the seeds of milk thistle (Silybum marianum) and is known to have antioxidative and anti-apoptotic properties. Furthermore, it has been demonstrated that its anti-oxidative activity is related to the scavenging of free radicals and activation of anti-oxidative defenses: increases in cellular glutathione content and superoxide dismutase activity. Milk thistle has been used for a range of psychiatric disorders including methamphetamine abuse and obsessive compulsive disorder. The flavonoid complex silymarin in preclinical studies has been found to increase serotonin and dopamine levels in the cortex. In the frontal cortex one of the functions of dopamine is to increase the signal to noise ratio, increased dopamine correlating with increased frontal performance. Studies have shown that the higher cortical dopamine levels are associated with improved frontal cortical cognitive performance. Cortical inhibition is felt to be the basis for top-down control of motivated behaviors. A recent randomized controlled study with milk thistle was conducted in Iran Thirty five participants with moderate OCD were randomly assigned to 200 mg of milk thistle leaf extract or 10 mg of fluoxetine three times daily for eight weeks. Results revealed no significant difference in treatment effects between milk thistle and fluoxetine from baseline to endpoint as both interventions provided a highly significant reduction in symptoms. Silymarin or Milk Thistle may therefore offer promise for the treatment of individuals with trichotillomania.

The current pilot study examines the tolerability and efficacy of milk thistle in the treatment of trichotillomania in children and adults. The investigators hypothesize that milk thistle will reduce the severity of symptoms related to trichotillomania and improve patients' overall functioning.

Arms: arm 1: Each subject will have a 6 week treatment phase with milk thistle. arm 2: 6 week placebo phase before or after milk thistle phase depending on randomization.
Interventions: intervention 1: Milk Thistle intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_000.pdf: 
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4/19/2017 
 
 
 
 
 
 
 
Silymarin Treatment of Trichotillomania in Children and Adults:  
A Double-Blind, Placebo-Controlled, Cross-Over Study  
 
 
Jon E. Grant, M.D. 
 
University of Chicago 
 
 
 
 
 
Project Goals 
 
The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk 
thistle) in children and adults with trichotillomania.  The hypothesis to be tested is that silymarin 
will be more effective and well tolerated in children and adults with trichotillomania compared to 
placebo. The proposed study will provide needed data on the treatment of a disabling disorder 
that currently lacks a clearly effective treatment. 
 
Specific Aims 
The primary aim of this application is to conduct a randomized placebo-controlled 
pharmacotherapy trial using silymarin (milk thistle) in 25 participants with trichotillomania. The 
study will consist of three phases: a 6 week active treatment phase with milk thistle, a 6 week 
placebo phase, and a 1 week wash-out period between the two 6 week phases. The subjects will 
be randomized to either receive active or placebo treatment in the first 6 weeks, and the other 
during the remaining 6 week phase. 
This will be one of few studies assessing the use of pharmacotherapy for the treatment of 
trichotillomania in children and adults. Assessing the efficacy and safety of silymarin (milk 
thistle), will help inform clinicians about additional treatment options for children and adults 
suffering from this disorder. 
The antioxidant, milk thistle, offers a unique mechanism to address the inability to 
control a behavior as seen in trichotillomania. Cognitive research suggests that trichotillomania 
is characterized as a disorder of response inhibition. Although many people may pull a hair 
occasionally, the inability to stop the pulling once it has started is the hallmark of 
trichotillomania. Milk thistle appears to increase dopamine in the prefrontal cortex and thereby 
improve a range of cognitive functions, such as planning, response flexibility, and response 
inhibition. The proposed study will allow us to investigate baseline cognitive aspects of children 
and adults with trichotillomania and examine the impact of drug treatment on tasks of cognitive 
control.  


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4/19/2017 
Aim 1: We will examine the effects of milk thistle versus placebo in children and adults 
with trichotillomania. By targeting deficits in cognitive control, milk thistle may offer a unique 
mechanism to address compulsive behaviors. We hypothesize that milk thistle will be more 
effective than placebo in reducing hair pulling behavior during an acute treatment period.   
Aim 2: Because lack of cognitive control may underlie a range of body-focused repetitive 
behaviors, and improvement in related systems may be secondary to greater control, we will 
examine levels of cognitive control using cognitive tasks pre- and post-treatment. This study will 
examine cognitive deficits across a range of prefrontal-dependent domains which have been 
associated with trichotillomania – response inhibition, working memory, cognitive flexibility and 
planning ability - as possible predictors of treatment and as possible biomarkers for underlying 
pathophysiology of hair pulling behavior.  We hypothesize that improvement in response 
inhibition will be greater in participants who receive milk thistle compared with placebo. 
 
Background and Significance 
 
Pathological hair-pulling, trichotillomania, has been defined as repetitive, intentionally 
performed pulling that causes noticeable hair loss and results in clinically significant distress or 
functional impairment (1). Trichotillomania appears relatively common with an estimated 
prevalence between 1-3% (2). Data on the pharmacological treatment of trichotillomania is 
limited to case reports and conflicting double-blind studies of serotonin reuptake inhibitors (3). 
One positive double-blind study of N-acetyl cysteine in adults was not successful when 
examined for children and adolescents (4-5). Available data on the treatment of trichotillomania 
in children are therefore limited. 
Silymarin, a flavonoid and a member of the Asteraceae family, is extracted from the 
seeds of milk thistle (Silybum marianum) and is known to have antioxidative and anti-apoptotic 
properties. Furthermore, it has been demonstrated that its anti-oxidative activity is related to the 
scavenging of free radicals and activation of anti-oxidative defenses: increases in cellular 
glutathione content and superoxide dismutase activity. Milk thistle has been used for a range of 
psychiatric disorders including methamphetamine abuse and obsessive compulsive disorder. The 
flavonoid complex silymarin in preclinical studies has been found to increase serotonin and 
dopamine levels in the cortex (6).  In the frontal cortex one of the functions of dopamine is to 
increase the signal to noise ratio, increased dopamine correlating with increased frontal 
performance (7). Studies have shown that the higher cortical dopamine levels are associated with 
improved frontal cortical cognitive performance (8).  Cortical inhibition is felt to be the basis for 
top-down control of motivated behaviors. A recent randomized controlled study with milk thistle 
was conducted in Iran Thirty five participants with moderate OCD were randomly assigned to 
200 mg of milk thistle leaf extract or 10 mg of fluoxetine three times daily for eight weeks. 
Results revealed no significant difference in treatment effects between milk thistle and fluoxetine 
from baseline to endpoint as both interventions provided a highly significant reduction in 
symptoms (9).  Silymarin or Milk Thistle may therefore offer promise for the treatment of 
individuals with trichotillomania. 
The current pilot study examines the tolerability and efficacy of milk thistle in the 
treatment of trichotillomania in children and adults. We hypothesize that milk thistle will reduce 
the severity of symptoms related to trichotillomania and improve patients’ overall functioning. 
 
 
Methodology 


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4/19/2017 
 
The proposed study will consist of a 13 week double-blind cross-over study trial of milk 
thistle in 25 people (ages 10-65). The study will be divided into an initial 6 week phase, a 1 week 
wash-out phase, and a second 6 week phase, with one of the 6 week phases consisting of active 
treatment with milk thistle, and one of the 6 week phases consisting of inactive placebo 
treatment. Participants will be randomized to receive either milk thistle or placebo during the 
first 6 week phase on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the 
University of Chicago. 
 
Subjects:  
Inclusion criteria:  
1) Males and females age 10-65;  
2) Diagnosis of current trichotillomania (TTM) based on DSM-5 criteria and confirmed using the 
clinician-administered Structured Clinical Interview for DSM-5 (SCID);  
3) Hair-pulling behavior within 2 weeks prior to enrollment; 
4) If under 18, child able and willing to provide active assent for participation; 
5) If under 18, legal guardian available to provide consent for participation. 
6) If 18 or older, able to provide written consent for participation. 
 
Exclusion criteria:  
1) Infrequent hair-pulling (i.e. less than one time per week) that does not meet DSM-5 criteria for 
trichotillomania;  
2) Unstable medical illness as determined by the investigator; 
3) History of seizures;  
4) Current use of stimulants coinciding with onset or exacerbation of trichotillomania symptoms 
or other current medications coinciding with exacerbation or onset or trichotillomania symptoms; 
5) Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale);  
6) Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS); 
7) Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any psychotic disorder, 
or any substance use disorder;  
8) Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;  
9) Previous treatment with milk thistle; 
10) Any history of psychiatric hospitalization in the past year; 
11) Currently pregnant (confirmed by urine pregnancy test) 
 
Consent Procedures 
As part of the target population is a vulnerable population, additional procedures will be 
in place to ensure enrollment and consent processes. During the consent processes, each child 
will be asked to provide active verbal or written assent to participate in the study. A refusal to 
respond or inaction will be taken as a denial of assent. The child will also be asked to complete a 
separate assent form, including simplified language to describe the study. Additionally, a legal 
guardian for each child will be asked to read and sign an accompanying consent form to 
participate in the study. It will be made clear to the child and his/her guardian that they are free 
to withdraw from the study at any time if they wish to withdraw their assent to participate. 
 
Data Handling and Record Keeping 


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4/19/2017 
All subject data will be maintained by the study personnel under the supervision of the 
principal investigator.  All subjects will be seen in the Department of Psychiatry at the University 
of Chicago Medical Center at 5841 South Maryland Avenue. Patient binders will be kept in a 
locked room only accessible to research staff.   
 
Finance and Insurance 
All research will be paid for by the internal departmental funds of the Department of 
Psychiatry at the University of Chicago. In the event that this research activity results in an 
injury, treatment will be available, including first aid, emergency treatment and follow-up care as 
needed. Care for such injuries will be billed in the ordinary manner to the subjects’ insurance 
company.  If the subject believes that they have suffered a research related injury, they will be 
instructed to inform the principal investigator immediately. 
 
Compensation 
For participating in the study, participants will receive $10 per visit to be paid in the form 
of one ten dollar (US$10.00) bill at the completion of each visit. Parking vouchers will also be 
provided for subjects as-needed. 
 
Time Line  
Recruitment for the proposed study will begin as soon as study drug is available. It is 
anticipated that all subjects would be entered into the study within approximately 12 months, and 
that the study would be completed within 15 months of initiation. 
 
Study Design 
 
The study is a 13-week, double-blind, placebo-controlled, pilot study of the safety and 
efficacy of milk thistle for children and adults with trichotillomania. All eligible study subjects 
will go through a 6-week treatment phase during which they will begin milk thistle at 300mg 
twice a day. Subjects will be given a matching placebo during the 6-week placebo phase. 
Subjects will be seen for scheduled study visits every two weeks during the 6-week blinded 
phases, with an additional visit one week after the end of the first 6 week phase, corresponding 
with the end of the 1 week wash-out period. Subjects will be randomized to either receive either 
the active of placebo condition during the first 6-week phase, and the remaining condition during 
the second 6-week phase. All efficacy and safety assessments will be performed at each visit.  
Subjects who are not compliant with their use of study medication (i.e. failing to take medication 
for three or more consecutive days) will be discontinued from the study.  Patients who 
experience a clinically significant adverse event will also be discontinued from the study. 
 
 
Screening Assessments  
 
1. Demographic data and clinical characteristics will be recorded for each subject (baseline 
visit). 
2. Formal screening psychiatric interview for each subject including the Mini International 
Neuropsychiatric Inventory (10) (baseline visit). 
3. Symptom severity at baseline and follow-up visits will be examined using reliable and valid 
scales: 
a. Massachusetts General Hospital Hairpulling Scale (MGH-HPS) (11) (each visit) 


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4/19/2017 
b. Trichotillomania Scale for Children, Child Version (TSC-C) (12) (each visit) 
(only for children under the age of 18 who are participating in the study) 
c. Trichotillomania Scale for Children, Parent Version(TSC-P) (12) (each visit) 
(only for parents of children under the age of 18 who are participating in the 
study) 
d. NIMH Trichotillomania Symptom Severity Scale (TSS) (13) (each visit) 
e. Clinical Global Impression severity and improvement scales (14) (each visit) 
f. Sheehan Disability Scale (15) (baseline and final visit) 
g. Hamilton Anxiety Rating Scale (HAM-A) (16) (each visit) 
h. Hamilton Depression Rating Scale (HAM-D) (17) (each visit) 
i. Lie Acceptability Scale (Baseline) 
j. The Narcissistic Personality Inventory 16 (Baseline) 
k. The Social Desirability Scale (Baseline) 
 
 
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) (11). The MGH-HPS is a 7-
item, self-report scale that rates urges to pull hair, actual amount of pulling, perceived control 
over behavior, and distress associated with hair pulling over the past seven days. Analysis of the 
MGH-HPS has demonstrated two separate factors with acceptable reliability for both: “severity” 
and “resistance and control.”   
 
Trichotillomania Scale for Children (TSC-C & TSC-P) (Parent and Child Versions) (12). The 
TSC is a validated measure of trichotillomania symptom severity in children. These scales assess 
parent and child reports of frequency of pulling behavior as well as other facets of severity and 
impairment. (Tolin et al., 2008) 
 
NIMH Trichotillomania Severity Scale (NIMH-TSS) (13). The NIMH scale is a 5-item, clinician-
administered scale that rates hair pulling symptoms during the past week. The items assess 
pulling frequency (both on the previous day and during the past week), urge intensity, urge 
resistance, subjective distress, and interference with daily activities. Four items are rated from 0 
(none) to 5 (most severe) and the final item is rated from 0 to 4. A total score is calculated by 
summing all the item scores. The NIMH-TSS has demonstrated sensitivity to changes in 
symptom severity. 
 
Clinical Global Impression- Severity and Improvement (CGI) (14). The CGI consists of a 
reliable and valid 7-item Likert scale used to assess severity and improvement in clinical 
symptoms. The CGI severity scale was used at each visit and ranges from 1 = “not ill at all” to 7 
= “among the most extremely ill.”  The CGI Improvement scale was used at each follow-up visit 
and ranges from 1 = “very much improved” to 7 = “very much worse.”  
 
Sheehan Disability Scale (SDS) (15). The SDS is a three-item, reliable and valid self-report scale 
that assesses functioning in three areas of life: work, social or leisure activities, and home and 
family life. Scores on the SDS range from 0 to 30.  
 
Hamilton Anxiety Rating Scale (HAM-A) (16). The HAM-A is a reliable and valid, clinician-
administered, 14-item scale that provides an overall measure of global anxiety. 
 
 
 


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Hamilton Depression Rating Scale (HAM-D) (17).The HAM-D is a valid and reliable, 17-item, 
clinician-administered rating scale assessing severity of depressive symptoms.  
 
Cambridge-Chicago Trait Scale (Cambridge CHI-T Scale) (18). The CHI-T scale is a 16-item 
self-report scale that measures compulsivity. 
 
Lie Acceptability Scale (Goosie, 2014): An 11-item self-report questionnaire which assesses an 
individual’s perception of the acceptability of lying across several dimensions. 
 
The Narcissistic Personality Inventory 16 (Raskin & Terry, 1988): The NPI-16 is a short 
measure of subclinical narcissism that has shown meaningful face, internal, discriminant, and 
predictive validity. It can serve as an alternative measure of narcissism when situations do not 
allow the use of longer inventories. 
 
The Social Desirability Scale (Crowne & Marlowe, 1960): A 33-item self-report questionnaire 
which assesses the degree to which individuals report the outcome that is most socially desirable 
using true/false questions. 
 
 
Cognitive Assessments: In addition, subjects will undergo cognitive assessments at baseline and 
study endpoint. Assessments of cognitive control will be comprised of several valid paradigms 
(Table 1). These tasks are designed to probe dissociable neural circuitry and cognitive processes 
likely to be implicated in the pathophysiology of body-focused repetitive behaviors. Task order 
will be chosen arbitrarily and will be applied consistently across subjects, to minimize possible 
confounding factors of differences in task order across participants. 
 
Table 1.Neurocognitive Tasks 
Task 
Target Cognitive Process 
MOT 
Training Task. 
Intra-dimensional/Extra-dimensional 
Set Shift Task (ID/ED task)  
Intra- and extra-dimensional thinking ability. Assesses 
cognitive flexibility. 
Stop-Signal Task of Inhibitory 
Control  
Motor impulsivity and response inhibition. 
Tower of London Task  
Problem solving and logic task. 
Cambridge Gamble Task 
Decision making and risk adjustment. 
RVP 
Visual processing abilities. 
SWM 
Spatial working memory abilities. 
 
Efficacy Assessments 
 
The primary outcome measure will be the NIMH Trichotillomania Severity Scale 
(NIMH-TSS). The NIMH-TSS is a reliable and valid scale that is frequently used in research to 
assess symptom severity. 
Secondary efficacy measures include 
 The Clinical Global Impression-Improvement and Severity scales (CGI) 
 Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) 


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4/19/2017 
 Trichotillomania Scale for Children (TSC-C & TSC-P) (Parent and Child 
Versions) 
 Sheehan Disability Scale (SDS) 
 Hamilton Anxiety Rating Scale (HAM-A) 
 Hamilton Depression Rating Scale (HAM-D). 
 Cambridge-Chicago Trait Scale (Cambridge CHI-T Scale) 
 
 
Safety Assessments 
Safety assessments (sitting blood pressure, heart rate, adverse effects, and concomitant 
medications) will be documented at each visit.  
Suicidality will be assessed using the Columbia Suicide Severity Rating Scale.  This scale 
will be performed at every visit. Subjects who endorse suicidal thoughts at any time during the 
study will be removed from the study and appropriate clinical intervention (e.g. hospitalization) 
will be arranged.  
The investigator will record use of concomitant medications in terms of daily dosage, 
start and stop dates, and reason for use. Adverse events will be recorded at each study visit and 
as they become known to the study staff. Medication compliance will be ascertained through 
weekly pill count of investigational medication.  
 
Risks and Benefits 
Risks 
 
Potential risks during the study include side effects from the active milk thistle. The most 
common side effects include: 
 Upset stomach 
 Diarrhea 
 Headaches 
 Bloating 
In rare cases, other side effects may occur. In the event of one of these changes, participants and 
guardians will be instructed to contact the study doctor immediately: 
 A skin rash 
 Respiratory distress. 
It is also possible that the questions regarding symptoms related to trichotillomania, depression, 
or mental health may be distressing, especially for children. Special precautions will be taken to 
allow the child to adjust to the study environment and provide opportunities for the child to 
check in with study staff about any current discomfort. There may be other risks that could arise 
which are not reasonably foreseeable. If new information becomes available, study staff will 
make this information available to participants and legal guardians immediately. 
 
Benefits 
 
Potential benefits include a possible direct medical benefit. Specifically, the study drug 
may help curb the severity of symptoms related to trichotillomania, but there can be no guarantee 
that this will be the case. 
 
This research provides substantial benefit for current treatments for trichotillomania, 
particularly in children. As there is currently little to no research in this area, the current study 
could offer significant advancement in possible treatments for this disorder. 
 


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Data Analysis 
Demographic and baseline visit characteristics for milk thistle and placebo groups will be 
compared using chi-square and analysis of variance to determine if group differences existed at 
ranodmization. Given the crossover design, both the placebo and the active milk thistle groups 
will contain an N of 25. Primary and secondary measures will be examined using repeated-
measures ANOVA modeling analyses (PROC MIXED, SAS/STAT Software for Windows, 
Version8.2, SAS Institute Inc., Cary, NC, USA). The baseline value of the measure being 
analyzed will be used as a covariate. A time trend (linear) will be included in all models. The 
difference in the overall level of posttreatment values, the main effect for treatment, will be the 
test of primary interest. Analyses will be performed on all available data as well as for the 
completers. All available post-randomization data will be first analyzed and a secondary, 
supportive analysis of completers will be performed. All comparison tests will be two-tailed and 
an alpha level of .05 will be used to determine statistical significance given the exploratory 
nature of the study.  
 
 
Ethical Considerations 
 
This study will be conducted according to US and international standards of Good 
Clinical Practice (FDA regulations 21 CFR 312 for IND studies and FDA guidance E6) for all 
studies.  Applicable government regulations and University of Chicago research policies and 
procedures will also be followed. This protocol and any amendments will be submitted to the 
University of Chicago Institutional Review Board (IRB) for formal approval to conduct the 
study.  The decision of the IRB concerning the conduct of the study will be made in writing to 
the investigator. 
Special attention will be paid to ensuring that the participants feel comfortable in the 
study settings. Children will be given the option of having a guardian sit in on study visits, or 
asking them to wait in a designated area. Should significant problems arise, the legal guardian 
will be made aware of issues on behalf of the child in question. 
 
 
 
 REFERENCES 
 
 
1. American Psychiatric Association. (2013) Diagnostic and Statistical Manual of Mental 
Disorders. 5th ed. Washington, D.C. 
2. Christenson GA, Pyle RL, Mitchell JE. Estimated lifetime prevalence of trichotillomania in 
college students. J Clin Psychiatry. 1991; 52:415-417. 
3. Chamberlain SR, Odlaug BL, Boulougouris V, Fineberg NA, Grant JE. Trichotillomania: 
neurobiology and treatment. Neurosci Biobehav Rev, 2009; 33:831-842 
4. Grant JE, Odlaug BL, Kim SW. N-acetylcysteine, a glutamate modulator, in the treatment of 
trichotillomania: a double-blind, placebo-controlled study. Arch Gen Psychiatry, 
2009; 66:756-763. 
5. Bloch MH, Panza KE, Grant JE, Pittenger C, Leckman JF. N-Acetylcysteine in the treatment 
of pediatric trichotillomania: a randomized, double-blind, placebo-controlled add-on 
trial. J Am Acad Child Adolesc Psychiatry, 2013; 52:231-240. 


9 
 
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6. Yaghmaei P, Oryan S, Mohammadi K, Solati J. (2012). Role of serotonergic system on 
modulation of depressogenic-like effects of silymarin. Iran J Pharm Res, 11:331-337. 
7. Lu P, Mamiya T, Lu L, Mouri A, Niwa M, Kim HC, Zou LB, Nagai T, Yamada K, Ikejima T, 
Nabeshima T. Silibinin attenuates cognitive deficits and decreases of dopamine and 
serotonin induced by repeated methamphetamine treatment. Behav Brain Res, 2010; 
207:387-393. 
8. Seamans JK, Yang CR. The principal features and mechanisms of dopamine modulation in the 
prefrontal cortex. Prog Neurobiol, 2004; 74:1-58. 
9. Sayyah M, Boostani H, Pakseresht S, Malayeri A. (2010). Comparison of Silybum marianum 
(L.) Gaertn with fluoxetine in the treatment of Obsessive-Compulsive Disorder. Prog 
Neuropsychopharmacol Biol Psychiatry, 2010; 34:362-365. 
10. Sheehan DV, Lecrubier Y, Sheehan KH, et al. (1998). "The Mini-International 
Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured 
diagnostic psychiatric interview for DSM-IV and ICD-10". J Clin Psychiatry. 59 
Suppl 20: 22–33. 
11.   Keuthen  NJ, O'Sullivan  RL, Ricciardi JN, Shera D, Savage CR, Borgmann AS, Jenike 
MA, Baer L. The Massachusetts General Hospital (MGH) Hair Pulling Scale, 1: 
development and factor analyses. Psychother Psychosom, 1995; 64:141-145. 
12. Tolin DF, Diefenbach GJ, Flessner CA, Franklin ME, Keuthen NJ, Moore P, Piacentini J, 
Stein DJ, Woods DW. Trichotillomania Learning Center Scientific Advisory Board. 
The trichotillomania scale for children: development and validation. Child Psychiatry 
Hum Dev, 2008; 39:331-349. 
13. Christenson GA. The assessment and treatment of trichotillomania. In: The Oxford 
Handbook of Impulse Control Disorders. Eds. Grant JE, Potenza MN. New York, 
NY: Oxford University Press; 2012: 313–333 
14. Guy W (1976). ECDEU Assessment Manual for Psychopharmacology. US Dept Health, 
Education and Welfare publication (ADM) 76-338. Rockville, MD: National Institute 
of Mental Health, 218-222. 
15. Sheehan DV. (1983). The Anxiety Disease. New York: Scribner's. 
16. Hamilton M. The assessment of anxiety states by rating. Br J Med Psychiatry, 1959; 32:50-
55.  
17. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry, 1960; 23:56-62. 
18. Grant JE, Chamberlain SR. Cambridge-Chicago Trait Scale. 2016. Copy available upon 
request.  
 

ICF_001.pdf: 
Page 1 of 7 
Version date:  2/20/18 
 
The UNIVERSITY OF CHICAGO 
The Division of the Biological Sciences  The University of Chicago Medical Center 
 
CONSENT/AUTHORIZATION BY SUBJECT FOR PARTICIPATION IN A 
RESEARCH PROTOCOL 
 
Protocol Number:  IRB15-0178           Name of Subject:   
 
 
______ 
 
 
STUDY TITLE:  Silymarin Treatment of Trichotillomania in Children and Adults: A 
Double-Blind, Placebo-Controlled, Cross-Over Study 
 
 
Doctors Directing Research: Dr. Jon E. Grant  
 
Address: University of Chicago Medical Center 
 
   Department of Psychiatry 
   5841 South Maryland Avenue, MC 3077 
   Chicago, IL 60637 
 
Telephone Number: 773-834-1325 
 
You are being asked to participate in a research study. A member of the research 
team will explain what is involved in this study and how it will affect you. This consent 
form describes the study procedures, the risks and benefits of participation, as well as 
how your confidentiality will be maintained. Please take your time to ask questions and 
feel comfortable making a decision whether it is in your interest to participate or not. This 
process is called informed consent.  If you decide you are willing to participate in this 
study, you will be asked to sign this form.  
 
WHY IS THIS STUDY BEING DONE? 
 
The purpose of this study is to evaluate the safety and effectiveness of milk thistle 
(silymarin) for children and adults with trichotillomania (hair pulling disorder). 
The hypothesis to be tested is that milk thistle will be more effective and well 
tolerated in subjects with trichotillomania compared to placebo (inactive drug). 
The proposed study will provide needed data on the treatment of trichotillomania 
in children and adults, a population that currently lacks a clearly effective 
treatment. 
 
 
Milk thistle is being used as an experimental drug for this study.  This means that 
milk thistle is not approved by the Food and Drug Administration for reducing the 
symptoms of trichotillomania.  
 
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY? 
About 25 people will take part in this study at the University of Chicago.  
 
WHAT IS INVOLVED IN THE STUDY? 


Page 2 of 7 
Version date:  2/20/18 
 
In order to determine if you are eligible to participate in the study, the following 
will take place: 
 A review of your medical history, current and past medications, and past 
treatments for trichotillomania will be completed.  
 You will undergo a psychiatric interview and be asked to complete some 
neurocognitive testing which measures how you act on thoughts (impulsivity) 
as well as your need to engage in a behavior (compulsivity). This testing 
involves three different tasks on the computer, measuring attention, 
impulsivity, and memory.    
 You will complete a physical exam with the study doctor; sitting blood 
pressure, pulse, temperature, weight, and height will be recorded. 
 You will be asked to give a urine sample that will be tested for drug use. This 
test must be negative in order to participate in the study. 
 If you are a female capable of having a child, you will complete a urine 
pregnancy test to ensure that you are not pregnant at the time of study entry.  
The pregnancy test must be negative in order to participate in the study. If you 
are sexually active, you also should be using appropriate contraceptives 
during the course of the study (including abstinence or other acceptable 
methods such as oral contraceptives (birth control pill), intrauterine device 
(IUD), injection/shot, male latex condom, vaginal ring, or birth control patch).  
 You will be asked about how you are feeling and if you have started taking 
any new medications or had any changes in medications recently.   
 You will be asked to complete questionnaires to assess mood and hair pulling. 
 You will receive the study drug or a placebo at the initial study visit to take in-
between visits at regular times over the course of the study.   
 This visit will take up to 2 hours.   
 
If you are determined to be eligible and provide consent to participate in this 
study, you will be enrolled in the study.  You will be asked to attend seven 
additional study visits where you will be given the study drug on visits 2, 3, 5, 6, 
and 7.   
 
 
For the first six weeks of the study, you will be assigned to receive either milk 
thistle (600mg) or placebo. You will be randomly assigned (randomization) to 
receive either the study drug or the placebo. Randomization means you will be 
assigned by chance to one group or the other, like flipping a coin. No individuals 
directly related to the study procedures (you or research staff) will know whether 
you are taking the study drug or the placebo.  This is what is meant by “blinding.”  
A placebo does not have any active ingredients but looks the same as the study 
drug.  
 
Whichever drug (milk thistle or placebo) is not assigned during the first six week 
phase will be assigned during the second six week phase following a one week 
wash-out period between phases.  
 


Page 3 of 7 
Version date:  2/20/18 
 
The study doctor will discuss the next study visit scheduling with you during each 
of the office visits. During visits 2, 3, 6, and 7, the following will occur: 
 
Your vital signs will be checked 
 
You will be given the study drug 
 
You will be asked to complete some questionnaires to assess mood and hair 
pulling since the last visit 
 
These visits will take approximately 30 minutes to one hour each.   
 
During visits 4, 5, and 8 you will be asked to complete the following: 
 Neurocognitive testing, which will consist of the same computer tasks you 
were asked to complete at the first visit.  
 Completing questionnaires and answering verbal questions about your hair 
pulling, thoughts about hair pulling, and mood.   
 Vital signs, including height, weight, blood pressure, and body 
temperature. 
 
During this study, Dr. Grant and his research team will collect information about 
you for the purposes of this research.  This information will include the following: 
your name, preferred contact information (address, email address, and telephone 
number), basic demographic information (such as date of birth, age, gender, and 
race), relationship status, sexual orientation, family and other history, medical and 
medication history, and responses from questionnaires. This information is being 
collected so that we are able to later evaluate your information and other 
participants’ to find correlations between certain characteristics, trichotillomania, 
and treatment outcomes.  
 
HOW LONG WILL I BE IN THE STUDY? 
 
We anticipate that you will be in the study for 13 weeks, with a total of eight 
visits.  
 
Dr.  Grant may decide to take you off of the study without your consent if: 
 You is unable to meet the requirements of the study; 
 Your medical condition changes; 
 The study drug is no longer available; 
 New information becomes available that indicates that participation in this 
study is not in your best interest; or 
 If the study is stopped. 
 
WHAT ARE THE RISKS OF THE STUDY? 
All drugs can cause side effects.  Side effects are usually reversible when the drug 
is stopped but occasionally continue and may cause serious complications. If you 
experience any side effects, you should contact the study doctor immediately.  
 
While taking the study drug, your condition may remain the same or worsen due 
to no effect of the study drug. 
 


Page 4 of 7 
Version date:  2/20/18 
 
The most common side effects associated with milk thistle include:  
 
upset stomach 
 
diarrhea 
 
headaches 
 
bloating 
 
Additionally, if you experience the following you should let the study doctor or 
staff know right away: 
 
a skin rash 
 
skin flushing 
 
drop in blood pressure 
 
irregular heart beat 
 
respiratory distress (i.e., problems breathing or chest tightening) 
 
It is possible that some of the questions on the surveys may cause discomfort or 
mental stress, such as “do you feel down or sad?” and specific questions that 
involve your hair pulling habits. If that should happen, study staff members are 
available to discuss any concerns or problems you may have.  Study personnel 
may remove subjects from this study who have suicidal thoughts.  In such a case, 
the study doctor will provide you with references to obtain additional help and 
appropriate treatment. 
 
There may be other risks that could arise which are not reasonably foreseeable. If 
new information becomes available which could influence your willingness to 
continue your participation, this information will be discussed with both you. 
 
ARE THERE ANY BENEFITS TO TAKING PART IN THE STUDY? 
If you agree to take part in this study, there may or may not be direct medical 
benefit to you.  The study drug may help your hair pulling, but there is no guarantee 
that the study drug will help you.  
 
We hope the information learned from this study will benefit both you and others 
with trichotillomania in the future. 
 
WHAT OTHER OPTIONS ARE THERE? 
Your participation is voluntary. Instead of being in this study, you may have these 
options: 
 
Receiving psychotherapy. While no medication has been approved for the 
treatment of trichotillomania, treatments without medication are available, 
including psychotherapy.   
 
Receiving no treatment 
 
The decision whether or not you wish to participate in this study will not affect 
your care at the University of Chicago Medical Center. 
 
WHAT ARE THE COSTS? 


Page 5 of 7 
Version date:  2/20/18 
 
Clinical services provided during a clinical trial are either research-related or 
related to usual medical care. Research-related services are done to complete the 
research and the costs are not the responsibility of you or your insurance.  
 
The costs that are considered research-related for this study include the following: 
All study drug (milk thistle or placebo) will be provided during the study, 
physical exams, urine pregnancy tests, urine drug tests, neurocognitive testing and 
interviews with the study doctor. 
 
Usual medical care costs include any and all services that are considered 
medically necessary for your disease. The cost of this usual, ongoing medical care 
will be the responsibility of you or your insurance, and may include deductibles 
and co-payments. Similarly, this care will be subject to all the same requirements 
and restrictions of your insurance.  
 
If you suffer an unanticipated injury as a direct result of this research and require 
emergency medical treatment, the University of Chicago Medical Center will 
provide such treatment at the University of Chicago Medical Center at no cost to 
you.  You must notify Dr. Grant as promptly as possible after your injury in order 
to receive this care.  An injury is “unanticipated” if it is not one of the known 
effects of a study drug, medical device or procedure, and is not the result of your 
disease or condition. The costs of any non-emergency care for such an injury will 
be billed to you or your insurance in the ordinary manner.  If you think that you 
have suffered a research related injury, you must let Dr. Grant know right away. 
 
WILL I BE PAID FOR MY PARTICIPATION? 
For participation in this study you will receive $10 per visit to be paid in the form 
of cash (US$10.00) at the end of each visit. This gives a total possible 
compensation of $80.   
 
You will also be compensated for your travel in the form of a parking voucher or 
bus voucher, which you will receive at the conclusion of each visit.  
 
WHAT ABOUT CONFIDENTIALITY? 
Study records that identify you will be kept confidential.  All records will be kept 
a secure office in a locked cabinet of the Psychiatry Department at the University 
of Chicago. Only study staff will have access to study records. The data collected 
in this study will be used for the purpose described in the form.  By signing this 
form, you are allowing the research team access to your medical records, which 
include Protected Health Information.  Protected Health Information (PHI) 
consists of any health information that is collected about you, which could include 
medical history and new information collected as a result of this study.  The 
research team includes the individuals listed on this consent form and other 
personnel involved in this study at the University of Chicago. 
 
Your records may be reviewed by federal agencies whose responsibility is to 


Page 6 of 7 
Version date:  2/20/18 
 
protect human subjects in research including the Food and Drug Administration 
(FDA) and Office of Human Research Protections (OHRP).  In addition, 
representatives of the University of Chicago, including the Institutional Review 
Board, a committee that oversees the research at the University of Chicago, may 
also view the records of the research.  If your research record is reviewed by any 
of these groups, they may also need to review your entire medical record.  
 
If health information is shared outside the University of Chicago, the same laws 
that the University of Chicago must obey may not protect your health 
information. 
 
During your participation in this study, you will have access to your medical 
record as appropriate. Dr. Jon Grant is not required to release to you research 
information that is not part of your medical record. 
 
This consent form will be kept by the research team for at least six years. The 
study results will be kept in your research record and be used by the research team 
indefinitely.  At the time of study completion, either the research information not 
already in your medical record will be destroyed or information identifying you 
will be removed from study results.  Any research information in your medical 
record will be kept indefinitely. 
 
Data from this study may be used in academic publications or presentations.  
Your name and other identifying information will be removed before this data is 
used.  If we wish to use identifying information in publications, we will ask for 
your approval. 
 
A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not 
include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this web site at any time. 
 
WHAT ARE YOUR RIGHTS AS A PARTICIPANT? 
Taking part in this study is voluntary.  If you choose not to participate in this 
study or decide to withdraw from the study your care at the University of 
Chicago/University of Chicago Medical Center will not be affected. You may 
choose not to participate at any time during the study. 
 
If you choose to no longer be in the study and you do not want any of your future 
health information to be used, you must inform Dr. Grant in writing at the address 
on the first page.  Dr. Grant may still use your information that was collected 
prior to your written notice.  
 
You will be given a signed copy of this document. This consent form document 
does not have an expiration date. 
 


Page 7 of 7 
Version date:  2/20/18 
 
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS? 
You have talked to study personnel about this study and you had the opportunity 
to ask questions concerning any and all aspects of the research.  If you have 
further questions about the study, you may call Dr. Grant at 773-834-1325. 
 
If you have a research related injury, you should immediately contact Dr. Grant 
(the study doctor) at 773-834-1325. 
 
If you have any questions concerning your rights in this research study you may 
contact the Institutional Review Board, which is concerned with the protection of 
subjects in research projects.  You may reach the Committee office between 8:30 
am and 5:00 pm, Monday through Friday, by calling (773) 702-6505 or by writing:  
Institutional Review Board, University of Chicago, 5841 S. Maryland Ave., 
MC7132, I-625, Chicago, Illinois  60637. 
 
 
CONSENT 
SUBJECT 
The research project and the procedures associated with it have been explained to 
me.  The experimental procedures have been identified and no guarantee has been 
given about the possible results. I will receive a signed copy of this consent form 
for my records. 
 
I agree to participate in this study.  My participation is voluntary and I do not 
have to sign this form if I do not want to be part of this research study. 
 
Signature of Subject:   
 
 
 
 
 
 
Date:    
 
 
Time:    
   AM/PM (Circle) 
 
 
 
PERSON OBTAINING CONSENT 
I have explained to        ___                                                                   ,  
the nature and purpose of the study and the risks involved.  I have answered and 
will answer all questions to the best of my ability.  I will give a signed copy of the 
consent form to the subject. 
 
Signature of Person Obtaining Consent:   
 
 
 
 
 
 
Date:    
 
 
Time:    
   AM/PM (Circle) 
 
 
INVESTIGATOR/PHYSICIAN: 
Signature of Investigator/Physician    
 
 
 
 
 
Date:    
 
 
Time:    
   AM/PM (Circle) 


 
1 
 
The UNIVERSITY OF CHICAGO 
The Division of the Biological Sciences  The University of Chicago Medical Center 
 
CONSENT/AUTHORIZATION BY SUBJECT FOR PARTICIPATION IN A 
RESEARCH PROTOCOL 
 
Protocol Number:  ___________        Name of Subject:   
 
 
 
 
 
STUDY TITLE:  Silymarin Treatment of Trichotillomania in Children: A Double-Blind,   
 
                 Placebo-Controlled, Cross-Over Study 
 
Doctors Directing Research: Dr. Jon E. Grant  
Address: University of Chicago Medical Center 
 
   Department of Psychiatry 
   5841 South Maryland Avenue, MC 3077 
   Chicago, IL 60637 
Telephone Number: 773-834-1325 
 
We are asking you to be in a research study.  We do research studies to learn more about how the 
body works and why people act the way they do.  If you decide to be in this study, you will be 
asked to sign your name at the end of this form. 
 
 
What we are asking you to do: 
In this study, we want to learn whether or not milk thistle helps people stop pulling their hair. 
We would like to ask you to take an experimental pill over the next few weeks and come in for 
visits every couple of weeks. We would also like you to fill out a few different questionnaires 
and play a couple of games on a computer during these visits.  During all parts of the visit you 
can let a member of the study staff know if any question makes you feel uncomfortable.   
 
About 10 kids will take part in this study at the University of Chicago. 
 
We think that you will be in the study for about 13 weeks which will include about 8 clinic visits. 
 
If you are sexually active, you have to be using contraceptives (birth control or condoms).  
 
Will being in this study hurt or help me in any way? 
All pills have some chance to cause problems, but these are usually reversible if you don’t take 
the pill anymore. Some problems that the pills in this study might cause are: upset stomach, 
diarrhea, headaches, or feeling “puffed-up”. 
 
If at any time you notice that you have a new rash, your skin feels weirdly hot, you get very light 
headed suddenly, your heart feels like it is beating weirdly, or you have any problems breathing, 
let a responsible adult know right away so they can call us, or call us directly at 773-834-3778. 
 


 
2 
 
Some of the questions we will ask you might make you feel uncomfortable. If that happens, you 
can tell us and we will skip those questions. You do not have to answer any questions that you do 
not want to answer. 
 
We don’t know if being in this study will help you. We hope that this study will help us to help 
other kids like you.  
 
What will you do with information about me? 
We will be very careful to keep your information from during the study private. Your doctors 
will not tell anyone else that you are in this study unless you say it is okay. Before and after the 
study we will keep all information we collect about you locked-up and password-protected.  
 
 
Do I have to be in this study? 
You do not have to participate in this study. It is entirely up to you.  You can say “no” now or 
you can even change your mind later.  No one will be upset with you if you decide not to be in 
this study, and you will still receive the money for the visits you have completed up until then.  
 
There is no punishment if you do not want to participate, and no one will force you to do 
anything you do not want to do. If you do not participate, you can let us or a responsible adult in 
your home know and you will not need to continue.   
 
If you want to stop being in the study, contact Dr. Jon Grant at 773-834-1325 or via email at 
jgrant4@bsd.uchicago.edu. You can choose not to be in this study at any time.  Your doctors will 
still try to make you feel better even if you don’t want to be in this study. 
 
 
If you have questions about the study, you can ask your mom or dad or contact: 
Dr. Jon Grant 
Ph: 773-834-1325 
Email: jgrant4@bsd.uchicago.edu. 
 
 
ASSENT: 
Please sign your name here if you want to be in this study. My parent/guardian will receive a 
copy of this form. 
 
Name of Subject (print): ________________________________________________ 
 
Subject’s Signature: ____________________________________________________ 
 
Date:  _____________  Time:   
 
   AM/PM (Circle) 
 
 
PERSON OBTAINING ASSENT: 


 
3 
 
I have explained to        ___                                                                   , the nature and purpose of 
the study and the risks involved.  I have answered and will answer all questions to the best of my 
ability.  I will give a signed copy of the assent form to the subject’s parent/legal guardian. 
 
Signature of Person Obtaining Assent:   
 
 
 
 
 
 
Date:    
 
 
Time:    
   AM/PM (Circle) 
 
INVESTIGATOR/PHYSICIAN: 
Signature of Investigator/Physician    
 
 
 
 
 
Date:    
 
 
Time:    
   AM/PM (Circle) 
 


Page 1 of 8 
Version date:  2/20/18 
 
The UNIVERSITY OF CHICAGO 
The Division of the Biological Sciences  The University of Chicago Medical Center 
 
CONSENT/AUTHORIZATION BY SUBJECT FOR PARTICIPATION IN A 
RESEARCH PROTOCOL 
 
Protocol Number:  _IRB15-0178        Name of Subject:   
 
 
 
 
 
STUDY TITLE:  Silymarin Treatment of Trichotillomania in Children: A Double-Blind,  
 
 
     Placebo-Controlled, Cross-Over Study 
 
 
Doctors Directing Research: Dr. Jon E. Grant  
Address: University of Chicago Medical Center 
 
   Department of Psychiatry 
   5841 South Maryland Avenue, MC 3077 
   Chicago, IL 60637 
Telephone Number: 773-834-1325 
 
Your child is being asked to participate in a research study. A member of the 
research team will explain what is involved in this study and how it will affect you and 
your child. This consent form describes the study procedures, the risks and benefits of 
participation, as well as how your child’s confidentiality will be maintained. Please take 
your time to ask questions and feel comfortable making a decision whether it is in your 
child’s interest to participate or not. This process is called informed consent.  If you 
decide you and your child are willing to participate in this study, you will be asked to 
sign this form, and your child will be asked to give assent in a related form.  
 
WHY IS THIS STUDY BEING DONE? 
 
The purpose of this study is to evaluate the safety and effectiveness of milk thistle 
(silymarin) for children with trichotillomania (hair pulling disorder). The 
hypothesis to be tested is that milk thistle will be more effective and well tolerated 
in subjects with trichotillomania compared to placebo (inactive drug). The 
proposed study will provide needed data on the treatment of trichotillomania in 
children, a population that currently lacks a clearly effective treatment. 
 
 
Milk thistle is being used as an experimental drug for this study.  This means that 
milk thistle is not approved by the Food and Drug Administration for reducing the 
symptoms of trichotillomania.  
 
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY? 
About 25 people will take part in this study at the University of Chicago.  
 
WHAT IS INVOLVED IN THE STUDY? 
In order to determine if your child is eligible to participate in the study, the 
following will take place: 


Page 2 of 8 
Version date:  2/20/18 
 
 The study will be discussed with you and you will be asked to sign this 
consent form.  
 The study will be discussed with your child and he/she will be asked to 
provide assent for participation on a related assent form. 
 A review of your child’s medical history, current and past medications, and 
past treatments for trichotillomania will be completed.  
 Your child will undergo a psychiatric interview and be asked to complete 
some neurocognitive testing which measures how he/she acts on thoughts 
(impulsivity) as well as his/her need to engage in a behavior (compulsivity). 
This testing involves three different tasks on the computer, measuring 
attention, impulsivity, and memory.   
 He/she will complete a physical exam with the study doctor; sitting blood 
pressure, pulse, temperature, weight, and height will be recorded. 
 He/she will be asked to give a urine sample that will be tested for drug use. 
This test must be negative in order to participate in the study. 
 If your child is a female capable of having a child, she will complete a urine 
pregnancy test to ensure that she is not pregnant at the time of study entry.  
The pregnancy test must be negative in order to participate in the study. If 
your child is sexually active, he/she also must be using appropriate 
contraceptives during the course of the study (including abstinence or other 
methods such as oral contraceptives (birth control pill), intrauterine device 
(IUD), injection/shot, male latex condom, vaginal ring, or birth control patch).  
 He/she will be asked about how he/she is feeling and if he/she has started 
taking any new medications or had any other changes in medications since the 
last visit.   
 He/she will be asked to complete questionnaires to assess mood and hair 
pulling. 
 If he/she qualifies for the study, you will receive the study drug or a placebo at 
the initial study visit to give your child in-between visits at regular times over 
the course of the study.   
 This visit will take up to 2 hours.   
 
If your child is determined to be eligible and provides assent to participate in this 
study, he/she will be enrolled in the study.  You and your child will be asked to 
attend seven additional study visits where your child will be given the study drug 
on visits 2, 3, 5, 6, and 7.   
 
For the first six weeks of the study, your child will be assigned to receive either 
milk thistle (600mg) or placebo.  Your child will be randomly assigned 
(randomization) to receive either the study drug or the placebo. Randomization 
means your child will be assigned by chance to one group or the other, like 
flipping a coin. No individuals directly related to the study procedures (you, your 
child, or research staff) will know whether your child is taking the study drug or 
the placebo.  This is what is meant by “blinding.”  A placebo does not have any 
active ingredients but looks the same as the study drug. Whichever drug (milk 
thistle or placebo) is not assigned during the first six week phase will be assigned 


Page 3 of 8 
Version date:  2/20/18 
 
during the second six week phase following a one week wash-out period between 
phases.  
 
The study doctor will discuss the next study visit scheduling with you and your 
child during each of the office visits. During visits 2, 3, 6, and 7, the following 
will occur: 
 
His/her vital signs will be checked 
 
He/she will be given the study drug 
 
He/she will be asked to complete some questionnaires to assess mood and hair 
pulling since the last visit 
 
These visits will take approximately 30 minutes to one hour each.   
 
During visits 4, 5, and 8 your child will be asked to complete the following: 
 Neurocognitive testing, which will consist of the same computer tasks 
he/she was asked to complete at the first visit. 
 Completing questionnaires and answering verbal questions about his/her 
hair pulling, thoughts about hair pulling, and mood.   
 Vital signs, including height, weight, blood pressure, and body 
temperature. 
 
During this study, Dr. Grant and his research team will collect information about 
your child for the purposes of this research.  This information will include the 
following: his/her name, preferred contact information (address, email address, 
and telephone number), basic demographic information (such as date of birth, age, 
gender, and race), relationship status, sexual orientation, family and other history, 
medical and medication history, and responses from questionnaires. This 
information is being collected so that we are able to later evaluate his/her 
information and other participants to find correlations between certain 
characteristics, trichotillomania, and treatment outcomes.  
 
HOW LONG WILL I BE IN THE STUDY? 
 
We anticipate that your child will be in the study for 13 weeks, with a total of 
eight visits.  
 
Dr.  Grant may decide to take your child off of the study without your consent if: 
 He/she is unable to meet the requirements of the study; 
 His/her medical condition changes; 
 The study drug is no longer available; 
 New information becomes available that indicates that participation in this 
study is not in your child’s best interest; or 
 If the study is stopped. 
 
WHAT ARE THE RISKS OF THE STUDY? 
All drugs can cause side effects.  Side effects are usually reversible when the drug 
is stopped but occasionally continue and may cause serious complications. If your 


Page 4 of 8 
Version date:  2/20/18 
 
child experiences any side effects, you should contact the study doctor 
immediately.  
 
While taking the study drug, your child’s condition may remain the same or 
worsen due to no effect of the study drug. 
 
The most common side effects associated with milk thistle include:  
 
upset stomach 
 
diarrhea 
 
headaches 
 
bloating 
 
Additionally, if your child experiences the following you should let the study 
doctor or staff know right away: 
 
a skin rash 
 
skin flushing 
 
drop in blood pressure 
 
irregular heart beat 
 
respiratory distress (i.e., problems breathing or chest tightening) 
 
It is possible that some of the questions on the surveys may cause discomfort or 
mental stress, such as “do you feel down or sad?” and specific questions that 
involve your child’s hair pulling habits. If that should happen, study staff 
members are available to discuss any concerns or problems you or your child may 
have.  Study personnel may remove subjects from this study who have suicidal 
thoughts.  In such a case, the study doctor will provide you with references to 
obtain additional help and appropriate treatment. 
 
There may be other risks that could arise which are not reasonably foreseeable. If 
new information becomes available which could influence your willingness to 
continue your child’s participation, this information will be discussed with both 
you and your child. 
 
ARE THERE ANY BENEFITS TO TAKING PART IN THE STUDY? 
If you agree to allow your child to take part in this study, there may or may not be 
direct medical benefit to your child.  The study drug may help your child’s hair 
pulling, but there is no guarantee that the study drug will help your child.  
 
We hope the information learned from this study will benefit both your child and 
others with trichotillomania in the future. 
 
WHAT OTHER OPTIONS ARE THERE? 
Your child’s participation is voluntary. Instead of being in this study, your child 
may have these options: 


Page 5 of 8 
Version date:  2/20/18 
 
 
Receiving psychotherapy. While no medication has been approved for the 
treatment of trichotillomania, treatments without medication are available, 
including psychotherapy.   
 
Receiving no treatment 
 
The decision whether or not you wish to have your child participate in this study 
will not affect your care or your child’s care at the University of Chicago Medical 
Center. 
 
WHAT ARE THE COSTS? 
Clinical services provided during a clinical trial are either research-related or 
related to usual medical care. Research-related services are done to complete the 
research and the costs are not the responsibility of you or your insurance.  
 
The costs that are considered research-related for this study include the following: 
All study drug (milk thistle or placebo) will be provided during the study, 
physical exams, urine pregnancy tests, urine drug tests, neurocognitive testing and 
interviews with the study doctor. 
 
Usual medical care costs include any and all services that are considered 
medically necessary for your child’s disease. The cost of this usual, ongoing 
medical care will be the responsibility of you or your insurance, and may include 
deductibles and co-payments. Similarly, this care will be subject to all the same 
requirements and restrictions of your insurance.  
 
If your child suffers an unanticipated injury as a direct result of this research and 
require emergency medical treatment, the University of Chicago Medical Center 
will provide such treatment at the University of Chicago Medical Center at no 
cost to you.  You must notify Dr. Grant as promptly as possible after your child’s 
injury in order to receive this care.  An injury is “unanticipated” if it is not one of 
the known effects of a study drug, medical device or procedure, and is not the 
result of your child’s disease or condition. The costs of any non-emergency care 
for such an injury will be billed to you or your insurance in the ordinary 
manner.  If you think that your child has suffered a research related injury, you 
must let Dr. Grant know right away. 
 
WILL I BE PAID FOR MY PARTICIPATION? 
For participation in this study you/your child will receive $10 per visit to be paid 
in the form of cash (US$10.00) at the end of each visit. This gives a total possible 
compensation of $80.   
 
You will also be compensated for your travel in the form of a parking voucher or 
bus voucher, which you will receive at the conclusion of each visit.  
 
WHAT ABOUT CONFIDENTIALITY? 
Study records that identify your child will be kept confidential.  All records will 


Page 6 of 8 
Version date:  2/20/18 
 
be kept a secure office in a locked cabinet of the Psychiatry Department at the 
University of Chicago. Only study staff will have access to study records. The 
data collected in this study will be used for the purpose described in the form.  By 
signing this form, you are allowing the research team access to your child’s 
medical records, which include Protected Health Information.  Protected Health 
Information (PHI) consists of any health information that is collected about your 
child, which could include medical history and new information collected as a 
result of this study.  The research team includes the individuals listed on this 
consent form and other personnel involved in this study at the University of 
Chicago. 
 
Your child’s records may be reviewed by federal agencies whose responsibility is 
to protect human subjects in research including the Food and Drug Administration 
(FDA) and Office of Human Research Protections (OHRP).  In addition, 
representatives of the University of Chicago, including the Institutional Review 
Board, a committee that oversees the research at the University of Chicago, may 
also view the records of the research.  If your child’s research record is reviewed 
by any of these groups, they may also need to review your child’s entire medical 
record.  
 
If health information is shared outside the University of Chicago, the same laws 
that the University of Chicago must obey may not protect your health 
information. 
 
During your participation in this study, you will have access to your child’s 
medical record as appropriate. Dr. Jon Grant is not required to release to you 
research information that is not part of your child’s medical record. 
 
This consent form will be kept by the research team for at least six years. The 
study results will be kept in your child’s research record and be used by the 
research team indefinitely.  At the time of study completion, either the research 
information not already in your child’s medical record will be destroyed or 
information identifying your child will be removed from study results.  Any 
research information in your child’s medical record will be kept indefinitely. 
 
Data from this study may be used in academic publications or presentations.  
Your child’s name and other identifying information will be removed before this 
data is used.  If we wish to use identifying information in publications, we will 
ask for your approval and your child’s assent at that time. 
 
A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not 
include information that can identify your child. At most, the Web site will 
include a summary of the results. You can search this web site at any time. 
 
WHAT ARE YOUR CHILD’S RIGHTS AS A PARTICIPANT? 


Page 7 of 8 
Version date:  2/20/18 
 
Taking part in this study is voluntary.  If your child chooses not to participate in 
this study, decides to withdraw from the study, or you decide to terminate his/her 
participation, your child’s care at the University of Chicago/University of 
Chicago Medical Center will not be affected. Your child may choose not to 
participate at any time during the study. 
 
If your child chooses to no longer be in the study and you do not want any of 
his/her future health information to be used, you must inform Dr. Grant in writing 
at the address on the first page.  Dr. Grant may still use your child’s information 
that was collected prior to your written notice.  
 
You will be given a signed copy of this document. This consent form document 
does not have an expiration date. 
 
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS? 
You have talked to study personnel about this study and you had the opportunity 
to ask questions concerning any and all aspects of the research.  If you have 
further questions about the study, you may call Dr. Grant at 773-834-1325. 
 
If your child has a research related injury, you should immediately contact Dr. 
Grant (the study doctor) at 773-834-1325. 
 
If you have any questions concerning your child’s rights in this research study you 
may contact the Institutional Review Board, which is concerned with the protection 
of subjects in research projects.  You may reach the Committee office between 8:30 
am and 5:00 pm, Monday through Friday, by calling (773) 702-6505 or by writing:  
Institutional Review Board, University of Chicago, 5841 S. Maryland Ave., 
MC7132, I-625, Chicago, Illinois  60637. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Page 8 of 8 
Version date:  2/20/18 
 
 
 
 
CONSENT 
 
PARENT/GUARDIAN/ OR LEGALLY AUTHORIZED REPRESENTATIVE: 
 
The research project and the procedures associated with it have been explained to 
me.  The experimental procedures have been identified and no guarantee has been 
given about the possible results. I will receive a signed copy of this consent form 
for my records. 
 
My child’s participation is voluntary and I do not have to sign this form if I do not 
want them to be part of this research study. 
 
I give my permission for my child/relative/the person I represent to 
participate in the above described research project. 
 
 
Name of Subject (print):   
 
 
 
 
 
 
 
 
Parent/Legal Guardian Signature:_________________________________ 
 
Date:    
 
 
Time:    
   AM/PM (Circle) 
 
 
PERSON OBTAINING CONSENT 
I have explained to        ___                                                                   ,  
the parent/legal guardian of __________________________________,  
the nature and purpose of the study and the risks involved.  I have answered and 
will answer all questions to the best of my ability.  I will give a signed copy of the 
consent form to the subject’s parent/legal guardian. 
 
Signature of Person Obtaining Consent:   
 
 
 
 
 
 
Date:    
 
 
Time:    
   AM/PM (Circle) 
 
INVESTIGATOR/PHYSICIAN: 
Signature of Investigator/Physician    
 
 
 
 
 
Date:    
 
 
Time:    
   AM/PM (Circle)