Clinical trial NCT05545891: Aripiprazole in Body Focused Repetitive Behaviors
Official title: A Double-Blind, Placebo Controlled Study of Aripiprazole in Body Focused Repetitive Behaviors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Trichotillomania (Hair-Pulling Disorder)
Dermatillomania
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is 6 weeks long and involves subjects taking aripiprazole or placebo. If they are randomly assigned to the aripiprazole arm and are eligible to participate in the study, they will begin by taking 5mg once daily of aripiprazole for two weeks, then 10mg once daily for the remaining three weeks. Efficacy and safety measures will be performed at each visit. Participants will be randomized to receive either aripiprazole or placebo on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.

Detailed description: The goal of the proposed study is to evaluate the efficacy and safety of aripiprazole in 100 subjects with DSM-5 trichotillomania (TTM) or skin picking disorder (SPD).

The hypothesis to be tested is that aripiprazole will be effective and well tolerated in patients with BFRBs (trichotillomania or skin picking disorder) compared to placebo. The proposed study will provide needed data on the treatment of disabling disorders that currently lack a clearly effective treatment.

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 aripiprazole will help inform clinicians about additional treatment options for adults suffering from this disorder.

Eligibility criteria: Inclusion Criteria:

1. Men and women age ≥18 years
2. current DSM-5 trichotillomania or skin picking disorder; and
3. Ability to understand and sign the consent form.

Exclusion Criteria:

1. Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
2. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
4. Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder
5. Illegal substance use based on urine toxicology screening
6. Stable dose of medications for at least the past 3 months
7. Previous treatment with aripiprazole
8. Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

Primary outcomes:
measure: NIMH Symptom Severity Scale (for TTM or Skin Picking)
timeFrame: The primary efficacy end points will be the change in these measures from baseline to week 6.
Secondary outcomes:
measure: Clinical Global Impressions-Improvement Scale (CGI-I)
timeFrame: 6 weeks
measure: Massachusetts General Hospital Hairpulling (Skinpicking) Scale
timeFrame: 6 weeks
measure: Skin Picking Symptom Assessment Scale
timeFrame: 6 weeks
measure: Quality of Life Inventory
timeFrame: 6 weeks
measure: Sheehan Disability Scale
timeFrame: 6 weeks
measure: Hamilton Depression Rating Scale
timeFrame: 6 weeks
measure: Hamilton Anxiety Rating Scale
timeFrame: 6 weeks
measure: Tridimensional Personality Questionnaire
timeFrame: 6 weeks
measure: Cambridge Caffeine Use Survey
timeFrame: 6 weeks
measure: Cambridge-Chicago Trait Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jon E Grant, MD, JD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.
citation: Grant JE, Odlaug BL, Chamberlain SR, Keuthen NJ, Lochner C, Stein DJ. Skin picking disorder. Am J Psychiatry. 2012 Nov;169(11):1143-9. doi: 10.1176/appi.ajp.2012.12040508.
citation: Grant JE, Odlaug BL, Hampshire A, Schreiber LR, Chamberlain SR. White matter abnormalities in skin picking disorder: a diffusion tensor imaging study. Neuropsychopharmacology. 2013 Apr;38(5):763-9. doi: 10.1038/npp.2012.241. Epub 2012 Nov 29.
citation: Grant JE, Chamberlain SR, Redden SA, Leppink EW, Odlaug BL, Kim SW. N-Acetylcysteine in the Treatment of Excoriation Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):490-6. doi: 10.1001/jamapsychiatry.2016.0060.
citation: Grant JE, Odlaug BL, Chamberlain SR, Kim SW. A double-blind, placebo-controlled trial of lamotrigine for pathological skin picking: treatment efficacy and neurocognitive predictors of response. J Clin Psychopharmacol. 2010 Aug;30(4):396-403. doi: 10.1097/JCP.0b013e3181e617a1.
citation: Woods DW, Flessner CA, Franklin ME, Keuthen NJ, Goodwin RD, Stein DJ, Walther MR; Trichotillomania Learning Center-Scientific Advisory Board. The Trichotillomania Impact Project (TIP): exploring phenomenology, functional impairment, and treatment utilization. J Clin Psychiatry. 2006 Dec;67(12):1877-88. doi: 10.4088/jcp.v67n1207.
citation: Bloch MH, Landeros-Weisenberger A, Dombrowski P, Kelmendi B, Wegner R, Nudel J, Pittenger C, Leckman JF, Coric V. Systematic review: pharmacological and behavioral treatment for trichotillomania. Biol Psychiatry. 2007 Oct 15;62(8):839-46. doi: 10.1016/j.biopsych.2007.05.019. Epub 2007 Aug 28.
citation: White MP, Koran LM. Open-label trial of aripiprazole in the treatment of trichotillomania. J Clin Psychopharmacol. 2011 Aug;31(4):503-6. doi: 10.1097/JCP.0b013e318221b1ba.
citation: Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.
citation: Turner GA, Sutton S, Sharma A. Augmentation of Venlafaxine with Aripiprazole in a Case of Treatment-resistant Excoriation Disorder. Innov Clin Neurosci. 2014 Jan;11(1-2):29-31.
citation: Gupta MA, Vujcic B, Pur DR, Gupta AK. Use of antipsychotic drugs in dermatology. Clin Dermatol. 2018 Nov-Dec;36(6):765-773. doi: 10.1016/j.clindermatol.2018.08.006. Epub 2018 Aug 16.
citation: Grant JE, Peris TS, Ricketts EJ, Bethlehem RAI, Chamberlain SR, O'Neill J, Scharf JM, Dougherty DD, Deckersbach T, Woods DW, Piacentini J, Keuthen NJ. Reward processing in trichotillomania and skin picking disorder. Brain Imaging Behav. 2022 Apr;16(2):547-556. doi: 10.1007/s11682-021-00533-5. Epub 2021 Aug 19.
citation: Swedo SE, Leonard HL, Rapoport JL, Lenane MC, Goldberger EL, Cheslow DL. A double-blind comparison of clomipramine and desipramine in the treatment of trichotillomania (hair pulling). N Engl J Med. 1989 Aug 24;321(8):497-501. doi: 10.1056/NEJM198908243210803.