Aripiprazole for Tourette Syndrome

Overseen By Madison P Collins, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Disqualifiers: Unstable medical illness, Pregnancy, Suicide risk, Psychosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether aripiprazole, a medication, can help people with Tourette Syndrome, which causes involuntary movements and sounds. Participants will take either aripiprazole or a placebo to assess the medication's effectiveness and safety over six weeks. The trial seeks individuals who have had Tourette Syndrome for at least two years and experience frequent tics that affect daily life. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been on a stable dose of any medications for at least the past 3 months.

Is there any evidence suggesting that aripiprazole is likely to be safe for humans?

Research has shown that aripiprazole is generally safe and effective for treating tics in children and teens with Tourette Syndrome. Studies have found that it reduces the severity of tics. However, some side effects may occur, particularly at higher doses. Although research highlights its safety, discussing potential side effects with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Tourette Syndrome?

Researchers are excited about aripiprazole for Tourette Syndrome because it offers a unique approach compared to traditional treatments like antipsychotics and alpha agonists. Aripiprazole works differently by acting as a partial agonist at dopamine receptors, which might help manage tics with potentially fewer side effects. This mechanism could provide a new option for those who struggle with the side effects of current medications, offering hope for a more tolerable treatment experience.

What evidence suggests that aripiprazole might be an effective treatment for Tourette Syndrome?

Research has shown that aripiprazole, which participants in this trial may receive, can help reduce the severity of tics in people with Tourette Syndrome. One study found that participants taking aripiprazole showed much greater improvement in their tics compared to those taking a placebo, which contains no active medicine. Another study found that aripiprazole not only reduced tics but also helped with other related issues. However, some side effects occurred, especially at higher doses. Overall, aripiprazole appears promising in managing symptoms of Tourette Syndrome. ^{1 2 4 6 7}

Who Is on the Research Team?

Jon E Grant, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either aripiprazole or placebo for 6 weeks. The dosage is 5mg once daily for the first three weeks, then 10mg once daily for the remaining three weeks.

6 weeks

Visits every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aripiprazole
• Placebo

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.

How Is the Trial Designed?

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 United States, European Union, Canada, Japan for the following indications:

Approved in United States as Abilify for:

• Irritability associated with autism spectrum disorder in children aged 6 to 17

Approved in European Union as Abilify for:

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

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+

Published Research Related to This Trial

A review of six randomized controlled trials involving 528 children and adolescents with Tourette's syndrome found that aripiprazole (ARI) has similar efficacy to other treatments like tiapride (TIA) and haloperidol (HAL) for controlling tic symptoms.

Importantly, ARI was associated with significantly fewer extrapyramidal symptoms compared to HAL, making it a safer alternative treatment option for managing Tourette's syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aripiprazole for Tourette's syndrome: a systematic review and meta-analysis. Zheng, W., Li, XB., Xiang, YQ., et al.[2022]

In a study involving 195 children aged 5-17 with Tourette syndrome, aripiprazole demonstrated similar efficacy to tiapride, with both treatments significantly reducing tic severity as measured by the Yale Global Tic Severity Scale (YGTSS) after 12 weeks.

Aripiprazole was found to be safe and well-tolerated, with comparable rates of adverse reactions to tiapride, suggesting it is a valid treatment option for tic disorders in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A multicenter controlled study on aripiprazole treatment for children with Tourette syndrome in China]. Liu, ZS., Chen, YH., Zhong, YQ., et al.[2016]

In a study of 29 patients with Tourette syndrome, aripiprazole was found to be safe and reasonably well tolerated, with a discontinuation rate of 20.7% due to adverse effects.

The most common side effects included sedation (30%) and sleep problems (17%), but most adverse effects were not severe, indicating that while some patients may experience issues, the overall tolerability of aripiprazole is favorable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability profile of aripiprazole in patients with Tourette syndrome. Cavanna, AE., Selvini, C., Termine, C., et al.[2015]

In a 10-week study involving 11 children and adolescents with Tourette's disorder, aripiprazole significantly reduced tic severity, with most participants showing marked improvement in their symptoms.

The treatment was generally safe and well-tolerated, although some participants experienced side effects like increased appetite, weight gain, and mild extrapyramidal symptoms, indicating the need for further controlled trials to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aripiprazole in children and adolescents with Tourette's disorder: an open-label safety and tolerability study. Lyon, GJ., Samar, S., Jummani, R., et al.[2021]

In a study of 24 children and adolescents with Tourette syndrome, aripiprazole showed a significantly greater reduction in tic severity compared to sodium valproate by the 5th and 10th days of treatment.

Both treatments were well-tolerated, with no significant differences in adverse reactions, suggesting that sodium valproate may provide a quicker onset of tic control compared to aripiprazole.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled clinical trial comparing the efficacy and tolerability of aripiprazole and sodium valproate in the treatment of Tourette syndrome. Tao, D., Zhong, T., Ma, S., et al.[2022]

In a 10-week study involving 61 children and adolescents with Tourette's disorder, aripiprazole significantly reduced tic severity compared to placebo, with a mean decrease in tic scores of -15.0 for aripiprazole versus -9.6 for placebo (P=.0196).

Aripiprazole was generally well tolerated, with no significant difference in adverse events compared to placebo, although it did lead to increased body weight and waist circumference, while also decreasing serum prolactin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter, randomized, double-blind, placebo-controlled study of aripiprazole in children and adolescents with Tourette's disorder. Yoo, HK., Joung, YS., Lee, JS., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11264494/

Randomized, double-blind, placebo-controlled trial of ... The aripiprazole group showed significantly greater improvement in the YGTSS-TTS from baseline to week 8 than the placebo group (least squares ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01727700

NCT01727700 | Study Evaluating the Safety and Efficacy of ... The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2025/06060/a_narrative_review_of_phase_iii_and_iv_clinical.53.aspx

A narrative review of Phase III and IV clinical trials for... Aripiprazole effectively reduced tic severity but with notable side effects, especially at higher doses. Efficacy & Safety Study of Once-weekly ...

4. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2016.00416/full

Aripiprazole Improves Associated Comorbid Conditions in ... Our results suggest that aripiprazole may improve associated comorbid conditions in addition to tics in patients with GTS.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5689110/

Randomized, Double-Blind, Placebo-Controlled Trial ... Conclusions: This study indicates that oral aripiprazole is a safe and effective treatment for tics in children and adolescents with TD. Keywords: : ...

6. capmh.biomedcentral.com capmh.biomedcentral.com/articles/10.1186/s13034-024-00764-6

Randomized, double-blind, placebo-controlled trial of ... Our findings suggest that aripiprazole oral solution is an effective, well-tolerated, and safe treatment for children and adolescents with TD.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28686474/

Randomized, Double-Blind, Placebo-Controlled Trial ... Conclusions: This study indicates that oral aripiprazole is a safe and effective treatment for tics in children and adolescents with TD.