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Atypical Antipsychotic
Aripiprazole for Tourette Syndrome
Phase 2
Waitlist Available
Led By Jon E Grant, MD, JD, MPH
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial is testing whether aripiprazole + memantine is better than aripiprazole + placebo for people with Tourette's.
Who is the study for?
This trial is for adults over 18 with trichotillomania or skin picking disorder who can consent to participate. Excluded are those at suicide risk, with unstable illnesses, pregnant or not using contraception, having certain psychiatric disorders, illegal substance use, recent medication changes, cognitive impairments, or past aripiprazole treatment.Check my eligibility
What is being tested?
The study compares the effects of a drug called Aripiprazole against a placebo in treating body-focused repetitive behaviors. Participants will take either the drug starting at 5mg and increasing to 10mg daily or a placebo for six weeks while their health is monitored.See study design
What are the potential side effects?
Aripiprazole may cause side effects such as restlessness, nausea, headaches, dizziness, insomnia and potential weight gain. Some people might also experience more serious effects like mood swings or movement disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Trichotillomania
Secondary outcome measures
Cambridge Caffeine Use Survey
Cambridge-Chicago Trait Scale
Clinical Global Impressions-Improvement Scale (CGI-I)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AripiprazoleExperimental Treatment1 Intervention
5mg once daily of aripiprazole for three weeks, then 10mg once daily for the remaining three weeks.
Group II: PlaceboPlacebo Group1 Intervention
5mg once daily of placebo for three weeks, then 10mg once daily for the remaining three weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aripiprazole
2012
Completed Phase 4
~5520
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,008 Previous Clinical Trials
822,150 Total Patients Enrolled
10 Trials studying Trichotillomania
404 Patients Enrolled for Trichotillomania
Jon E Grant, MD, JD, MPHPrincipal InvestigatorUniversity of Chicago
9 Previous Clinical Trials
381 Total Patients Enrolled
2 Trials studying Trichotillomania
43 Patients Enrolled for Trichotillomania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am not pregnant, breastfeeding, and I use effective birth control.I can understand and manage my medication, and I can give informed consent.I have been treated with aripiprazole before.My medication doses have been the same for the last 3 months.I have been diagnosed with a disorder that makes me pull out my hair or pick my skin.I have been diagnosed with trichotillomania or skin picking disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Aripiprazole
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Trichotillomania Patient Testimony for trial: Trial Name: NCT05545891 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently being sought for this clinical trial?
"According to the latest information on clinicaltrials.gov, this trial is no longer recruiting patients. The listing was originally posted on December 1st, 2022 and edited for the last time on October 28th, 2022. There are 6 other trials with open recruitment at this moment in time."
Answered by AI
Are there any dangers associated with Aripiprazole that patients should be aware of?
"Aripiprazole is a medication that, while having some supportive data for safety, has not yet been proven effective. Our team at Power have given it a 2."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Washington
Illinois
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
What site did they apply to?
University of Chicago
Why did patients apply to this trial?
I’ve struggled with trichotillomania since I was 10/11. It’s been debilitating and a huge blow to my confidence. Many years I’ve had no eyelashes or eyebrows. I would give anything to find a way to help this problem.
PatientReceived 1 prior treatment
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