A Double-Blind, Placebo Controlled Study of Aripiprazole in Body Focused Repetitive Behaviors
University of Chicago
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.
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. Assessin…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPlacebo
A drug that contains no medicine
- DrugAripiprazole
Atypical antipsychotic medication
Location
- University of ChicagoChicago, Illinois