Aripiprazole in Body Focused Repetitive Behaviors

May 11, 2023 updated by: University of Chicago

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
        • Principal Investigator:
          • Jon E Grant, MD, JD, MPH
        • Contact:
        • Contact:
          • P

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
5mg once daily of placebo for three weeks, then 10mg once daily for the remaining three weeks.
Drug: Placebo
A drug that contains no medicine
Experimental: Aripiprazole
5mg once daily of aripiprazole for three weeks, then 10mg once daily for the remaining three weeks.
Drug: Aripiprazole
Atypical antipsychotic medication
Other Names:
  • Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impressions-Improvement Scale (CGI-I)
Time Frame: 6 weeks
The entire study for the subject will last 6 weeks. Every two weeks the subject will complete the CGI. The change in scores from baseline to after 6 weeks will be assessed. The scale itself assesses overall disorder severity on a scale from 1 to 7 with 1 being "not at all" and 7 being "among the most severe cases"
6 weeks
Massachusetts General Hospital Hairpulling (Skinpicking) Scale
Time Frame: 6 weeks
Brief, self-report instrument for assessing repetitive hairpulling (skinpicking). Seven individual items, rated for severity from 0 to 4, assess urges to pull, actual pulling, perceived control, and associated distress.
6 weeks
Skin Picking Symptom Assessment Scale
Time Frame: 6 weeks
The entire study lasts 6 weeks. Every two weeks subjects will take the SP-SAS. The change in scores from baseline to after 6 weeks will be assessed. 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.
6 weeks
Quality of Life Inventory
Time Frame: 6 weeks
A self-report assessment of patient perceived quality of life that will be assessed at baseline and week 6. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life.
6 weeks
Sheehan Disability Scale
Time Frame: 6 weeks
Subjects will complete the SDS at all visits. The change in scores from baseline to study completion will be assessed. The scale itself assesses the level of disability from target disorder with higher scores indicating a more debilitating disorder.
6 weeks
Hamilton Depression Rating Scale
Time Frame: 6 weeks
A clinician-administered assessment of depression that will be assessed at all study visits. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms
6 weeks
Hamilton Anxiety Rating Scale
Time Frame: 6 weeks
A clinician-administered assessment of anxiety that will be assessed at all study visits. Changes in scores from baseline to final visit will be assessed. Higher scores indicate higher levels of anxiety, with 0 being no symptoms of anxiety.
6 weeks
Tridimensional Personality Questionnaire
Time Frame: 6 weeks
TPQ seeks to measure three dimensions (traits) of the personality. These personality traits are novelty seeking, harm avoidance and reward dependence. Each have four subscales. There are 100 true-false questions which form the basis for the computation of the traits.
6 weeks
Cambridge Caffeine Use Survey
Time Frame: 6 weeks
A self-report assessment that measures intake of different types of caffeine in the past week. Higher scores indicate more frequent caffeine use and lower scores indicate less frequent caffeine use. This will be assessed at all study visits.
6 weeks
Cambridge-Chicago Trait Scale
Time Frame: 6 weeks
A self-report assessment of compulsivity. Higher scores indicate greater compulsivity and lower scores indicate less compulsivity. This will be assessed at all study visits.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Jon E Grant, MD, JD, MPH, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2023

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB22-0616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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