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

100 Participants Needed

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.

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.

What data supports the effectiveness of the drug Aripiprazole for treating Tourette Syndrome?

Research shows that Aripiprazole is effective and safe for treating tics in children and adolescents with Tourette Syndrome. Studies found it to be well-tolerated with fewer side effects compared to other medications, and it helps reduce the severity of tics. ^{1 2 3 4 5}

Is aripiprazole safe for treating Tourette syndrome?

Aripiprazole is generally considered safe for treating Tourette syndrome, though some people may experience side effects like feeling sleepy or having trouble sleeping. About 20% of patients stopped using it due to side effects, but most side effects were not severe. ^{1 3 6 7 8}

How is the drug Aripiprazole unique for treating Tourette Syndrome?

Aripiprazole is unique for treating Tourette Syndrome because it is an atypical antipsychotic that has shown promise in reducing tics, especially in children and adolescents, with a focus on both effectiveness and tolerability. Unlike some other treatments, it has been systematically analyzed for its safety and efficacy in this specific condition. ^{1 3 7 9 10}

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

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

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

Treatment Details

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.

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 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+

Findings from Research

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]

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 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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A multicenter, randomized, double-blind, placebo-controlled study of aripiprazole in children and adolescents with Tourette's disorder. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and efficacy of aripiprazole for the treatment of pediatric Tourette syndrome and other chronic tic disorders. [2020]

3. China pubmed.ncbi.nlm.nih.gov

[A multicenter controlled study on aripiprazole treatment for children with Tourette syndrome in China]. [2016]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and tolerability of aripiprazole in children and adolescents with Tourette's disorder: a pilot study in China. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Tolerability profile of aripiprazole in patients with Tourette syndrome. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Aripiprazole for Tourette's syndrome: a systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Aripiprazole in children and adolescents with Tourette's disorder: an open-label safety and tolerability study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Tolerability of Aripiprazole in Children and Adolescents with Tourette's Disorder: A Meta-Analysis. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Aripiprazole treatment of children and adolescents with Tourette disorder or chronic tic disorder. [2021]