Memantine in Body Focused Repetitive Behaviors

Study Overview
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Brief Summary
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This study is 8 weeks long and involves subjects taking memantine or placebo. If they are randomly assigned to the memantine arm and are eligible to participate in the study, they will begin by taking 10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks. Efficacy and safety measures will be performed at each visit. Participants will be randomized to receive either memantine or placebo on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.

Detailed Description
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The goal of the proposed study is to evaluate the efficacy and safety of memantine in 100 subjects with DSM-5 trichotillomania (TTM) or skin picking disorder (SPD). The hypothesis to be tested is that memantine will be more effective and well tolerated in adults with trichotillomania or skin picking disorder compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder where there are not any current treatments options. This will be one of few studies assessing the use of pharmacotherapy for the treatment of TTM and SPD in adults. Assessing the efficacy and safety of memantine will help inform clinicians about additional treatment options for adults suffering from this disorder.

Official Title
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A Double-Blind, Placebo-Controlled Study of Memantine in Body Focused Repetitive Behaviors

Conditions
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Trichotillomania (Hair-Pulling Disorder), Dermatillomania

Intervention / Treatment
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* Drug: Placebo
* Drug: Memantine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women age ≥18 years; current DSM-5 trichotillomania or skin picking disorder; and Ability to understand and sign the consent form. Exclusion Criteria: Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination Current pregnancy or lactation, or inadequate contraception in women of childbearing potential Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs) Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder Illegal substance use based on urine toxicology screening Stable dose of medications for at least the past 3 months Previous treatment with memantine Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks | Drug: Placebo<br>* Pill that contains no medicine<br>* Other names: no other name;|
| Experimental: Memantine<br>10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks | Drug: Memantine<br>* Cognition-enhancing medication<br>* Other names: Namenda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIMH Symptom Severity Scale (for TTM or Skin Picking) | The primary efficacy measure will be the change in hair pulling or skin picking frequency and urges to pull hair or pick skin for the past week as indicated by change in total score. The entire study lasts 10 weeks. Every two weeks subjects will take the NIMH Symptom Severity Scale. The change in scores from baseline to after 8 weeks will be assessed. The scale itself assesses severity of trichotillomania or skin picking symptom, with higher scores indicating greater trichotillomania or skin picking severity. Score range: 0-20. | The primary efficacy end points will be the change in these measures from baseline to week 8. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions-Improvement Scale (CGI-I) | The entire study for the subject will last 8 weeks. Every two weeks the subject will complete the CGI-I. The scale is a clinician-rated measure of overall disorder severity. Scores range from 1 (not at all improved) to 7 (very much improved). In each group, the number of people in each group who had a CGI-I score of 6 or 7 at Week 8 (indicating much or very much improved) will be presented. | 8 weeks | 
| Massachusetts General Hospital Hairpulling (Skin Picking) Scale | Brief, self-report scale for assessing repetitive hairpulling (or skin picking). Because of a lack of an identical scale for skin-picking behavior, this scale was modified for skin picking for individuals with SPD to keep the outcome measure consistent across disorders. Seven individual items, rated for severity from 0 to 4, assess urges to pull (pick), actual pulling (picking), perceived control, and associated distress (range 0-28). The change in scores from baseline to after 8 weeks is reported. Negative values indicate a decrease in score from baseline to 8 weeks, while positive values indicate an increase in score from baseline to 8 weeks. | 8 weeks | 
| Skin Picking Symptom Assessment Scale | The entire study lasts 8 weeks. Every two weeks subjects will take the Skin Picking Symptom Assessment Scale (SP-SAS). The scale itself assesses severity of skin-picking symptoms. The SP-SAS score ranges from 0 to 48, with 0 being no symptoms and 48 being the most severe. The average change in score from baseline to Week 8 will be reported for both groups. A positive value indicates an increase in score from baseline to week 8, whereas a negative value indicates a decrease in score from baseline to week 8. | 8 weeks | 
| Sheehan Disability Scale | Subjects will complete the Sheehan Disability Scale (SDS) at all visits. The SDS is a self-report measure of functional impairment. Scores range from 0-30, with higher scores indicating greater functional impairment. The average change in score from baseline to Week 8 will be reported. Negative values indicate a decrease in score from baseline to Week 8, while positive values indicate an increase in score. | 8 weeks | 
| Hamilton Depression Rating Scale | A clinician-administered assessment of depression that will be assessed at all study visits. Score range 0-58. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms. The change in score from baseline to Week 8 is reported. Positive values indicate an increase in score from baseline to Week 8, whereas negative values indicate a decrease in score from baseline to Week 8. | 8 weeks | 
| Hamilton Anxiety Rating Scale | A clinician-administered assessment of anxiety that will be assessed at all study visits. Score range: 0-56. Higher scores indicate more anxiety symptoms, with 0 being no symptoms of anxiety. Changes in scores from baseline to week 8 visit will be assessed. Positive values indicate an increase in score from baseline to week 8, whereas negative values indicate a decrease in score from baseline to week 8. | 8 weeks |