Is there a study using Abilify (aripiprazole) for tic disorders?

Evidence for Aripiprazole (Abilify) in Tic Disorders

Yes, there is substantial evidence supporting the use of aripiprazole for tic disorders, including multiple randomized controlled trials and large case series demonstrating efficacy and safety in both pediatric and adult populations. 1, 2, 3

Guideline-Based Recommendations

Aripiprazole is recognized as an evidence-based anti-dopaminergic medication for treatment-refractory tic disorders, alongside haloperidol, pimozide, and risperidone. 4, 5 Guidelines specify that patients should be considered treatment-refractory only after failing behavioral techniques (habit reversal training, exposure and response prevention) and therapeutic doses of at least three proven medications, including anti-dopaminergic drugs and α-2 adrenergic agonists. 4

Clinical Trial Evidence

Randomized Controlled Trials

• Two RCTs in pediatric populations (ages 6-17) demonstrated significant efficacy: One trial with 218 children showed 56% positive response on aripiprazole 5 mg versus 35% on placebo, with significant improvements in irritability, hyperactivity, and stereotypy subscales. 4
• A second RCT with 98 children (ages 6-17) using flexibly-dosed aripiprazole (5-15 mg/d) confirmed these findings. 4
• Both trials used validated outcome measures including the Yale Global Tic Severity Scale and Clinical Global Impression scales. 3

Large-Scale Observational Data

• The largest case series to date included 100 patients (mean age 27.1 years) treated with aripiprazole 5-45 mg daily (mean 17 mg). 1 Eighty-two patients (82%) exhibited considerable reduction in tic severity, with 48 patients maintaining effective treatment for over 12 months. 1
• This study is particularly important because it provides robust evidence for adult populations, where RCT data remains limited. 1, 2

Pediatric-Specific Studies

• Multiple open-label studies in children ages 4-18 years consistently demonstrated efficacy using Yale Global Tic Severity Scale scores, with significant reductions in both motor and phonic tics. 3, 6
• One study of 16 children (ages 8-17) showed significant improvements in motor (p ≤ 0.0001), phonic (p ≤ 0.0001), and total tic scores (p ≤ 0.0001) at an average daily dose of 3.3 mg. 6

Comparative Effectiveness

An open-label comparative study of 48 children found aripiprazole equally effective to haloperidol in reducing tic severity, but with significantly fewer extrapyramidal symptoms during the first 4 weeks of treatment (p < 0.05). 7 This is clinically important because haloperidol, while FDA-approved for Tourette syndrome, carries higher risk of irreversible tardive dyskinesia. 5

Safety Profile

Aripiprazole demonstrates superior tolerability compared to typical antipsychotics: 3, 7

• Common adverse effects include sedation, weight gain, and nausea, which are typically transient and mild. 3
• In the large case series, 31% discontinued treatment due to inefficacy (7%), adverse effects (15% - drowsiness, agitation, weight gain, sleep disturbances), or both (4%). 1
• Extrapyramidal symptoms are less frequent than with typical antipsychotics. 7

Comorbidity Management

Aripiprazole may provide additional benefits for common comorbidities in tic disorders: 6

• ADHD (present in 50-75% of children with Tourette syndrome) 5, 8
• Obsessive-compulsive behaviors (present in 30-60% of cases) 5, 8
• Depression and anxiety 1

Five patients in the large case series reported beneficial effects on behavioral comorbidities including depression, anxiety, and autoaggression. 1

Dosing Considerations

Optimal dosing appears highly individualized, ranging from 5-45 mg daily in adults and 1.25-20 mg daily in children. 1, 6, 7 The mean effective dose in the largest adult series was 17 mg daily. 1 For pediatric patients, starting doses of 5 mg daily with gradual titration are recommended. 7

Critical Caveats

• Despite moderate-quality evidence in children, there remains a lack of robust RCT data in adults, though expert consensus and large observational studies support its use. 2
• Long-term efficacy and safety data beyond 12 months remain limited. 3
• Aripiprazole should only be used after behavioral interventions have been attempted and in patients with significant functional impairment. 4, 5