Aripiprazole in Body Focused Repetitive Behaviors

NCT05545891 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB22-0616
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Trichotillomania (Hair-Pulling Disorder); Dermatillomania

Outcome Measures

Primary Outcomes (1)

• 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 6 weeks. Every two weeks subjects will take the NIMH-TSS. The change in scores from baseline to after 6 weeks will be assessed. The scale itself assesses severity of trichotillomania symptoms. The NIMH-TSS score ranges from 0 to 20, with 0 being no symptoms and 20 being the most severe.

  The primary efficacy end points will be the change in these measures from baseline to week 6.

Secondary Outcomes (10)

• Clinical Global Impressions-Improvement Scale (CGI-I)

  6 weeks

• Massachusetts General Hospital Hairpulling (Skinpicking) Scale

  6 weeks

• Skin Picking Symptom Assessment Scale

  6 weeks

• Quality of Life Inventory

  6 weeks

• Sheehan Disability Scale

  6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

5mg once daily of placebo for three weeks, then 10mg once daily for the remaining three weeks.

Drug: Placebo

Aripiprazole

EXPERIMENTAL

5mg once daily of aripiprazole for three weeks, then 10mg once daily for the remaining three weeks.

Drug: Aripiprazole

Interventions

Placebo DRUG

A drug that contains no medicine

Placebo

Aripiprazole DRUG

Atypical antipsychotic medication

Also known as: Abilify

Aripiprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 aripiprazole
• Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (13)

• Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.

  PMID: 27581696 BACKGROUND

• 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.

  PMID: 23128921 BACKGROUND

• 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.

  PMID: 23303052 BACKGROUND

• 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.

  PMID: 27007062 BACKGROUND

• 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.

  PMID: 20531220 BACKGROUND

• 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.

  PMID: 17194265 BACKGROUND

• 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.

  PMID: 17727824 BACKGROUND

• 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.

  PMID: 21694623 BACKGROUND

• 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.

  PMID: 34582562 BACKGROUND

• 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.

  PMID: 24653940 BACKGROUND

• 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.

  PMID: 30446201 BACKGROUND

• 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.

  PMID: 34410609 BACKGROUND

• 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.

  PMID: 2761586 BACKGROUND

MeSH Terms

Conditions

Trichotillomania; Excoriation Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jon E Grant, MD, JD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madison P Collins, BA

CONTACT

773-834-3778; mcollins4@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)