Conditions: Tourette's Disorder Tic Disorder
Keywords: Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Tic Disorders Tics Movement Disorders Mental Disorders Aripiprazole
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 133
Healthy volunteers: no

Brief summary:
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 Tourette's Disorder.

Detailed description:
Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent, non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of medications approved for the treatment of Tourette's Disorder. The goal of the current trial is to obtain efficacy, safety, and tolerability data in a controlled condition of a Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder. The trial has an 8-week long double-blind treatment period after a pretreatment (screening/washout phase), and the subjects will be followed up for 1 month after the last treatment. The Once-daily tablet formulation that will be evaluated in this trial represents a daily dosage regimen that is intended to be administered to children and adolescents.

Arms:
arm 1: Matching Placebo Once-Daily arm 2: Aripiprazole 5 mg or 10 mg Immediate Release Once-Daily arm 3: Aripiprazole 10 mg 20 mg Immediate Release Once-Daily

Interventions: intervention 1: Aripiprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Once-daily, tablet intervention 2: None

Protocol document: