Aripiprazole for Tourette Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Jon E Grant, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Chicago

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jon E Grant, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

Ability to understand and sign the consent form

I have been diagnosed with a disorder that makes me pull out my hair or pick my skin.

Exclusion Criteria

Illegal substance use based on urine toxicology screening

Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination

Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)

Treatment Details

Interventions

• Aripiprazole (Atypical Antipsychotic)
• Placebo (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Aripiprazole Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Aripiprazole is already approved in Canada, Japan for the following indications:

Approved in Canada as Abilify for:

• Schizophrenia
• Bipolar I disorder
• Major depressive disorder
• Irritability associated with autistic disorder

Approved in Japan as Abilify for:

• Schizophrenia
• Bipolar disorder
• Major depressive disorder
• Irritability associated with pervasive developmental disorders

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago