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Not yet recruiting NCT05545891

Aripiprazole in Body Focused Repetitive Behaviors

Phase II Interventional Trichotillomania (Hair-Pulling Disorder) Dermatillomania

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, Aripiprazole.
Who it may be relevant to
Registry conditions: Trichotillomania (Hair-Pulling Disorder), Dermatillomania. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Double-Blind, Placebo Controlled Study of Aripiprazole in Body Focused Repetitive Behaviors

Overview

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.

Interventions

  • Drug Placebo
    A drug that contains no medicine
  • Drug Aripiprazole
    Atypical antipsychotic medication

Primary outcome measures

  • NIMH Symptom Severity Scale (for TTM or Skin Picking) [Time frame: The primary efficacy end points will be the change in these measures from baseline to week 6.]
Secondary outcome measures (10)
  • Clinical Global Impressions-Improvement Scale (CGI-I) [Time frame: 6 weeks]
  • Massachusetts General Hospital Hairpulling (Skinpicking) Scale [Time frame: 6 weeks]
  • Skin Picking Symptom Assessment Scale [Time frame: 6 weeks]
  • Quality of Life Inventory [Time frame: 6 weeks]
  • Sheehan Disability Scale [Time frame: 6 weeks]
  • Hamilton Depression Rating Scale [Time frame: 6 weeks]
  • Hamilton Anxiety Rating Scale [Time frame: 6 weeks]
  • Tridimensional Personality Questionnaire [Time frame: 6 weeks]
  • Cambridge Caffeine Use Survey [Time frame: 6 weeks]
  • Cambridge-Chicago Trait Scale [Time frame: 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Chicago — Chicago

Publications

  • Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432. PMID 27581696
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT05545891 · IRB22-0616

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗