Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Exclusion Criteria

• •Clinical presentation and/or history, consistent with another neurologic condition that may have accompanying abnormal movements.
• •History of schizophrenia, bipolar disorder, or other psychotic disorder.
• •Participant receiving psychostimulants for treatment of attention-deficit disorder/Attention-deficit hyperactivity disorder (ADD/ADHD) and who have developed and/or had exacerbations of tic disorder after initiation of stimulant treatment.
• •Currently meets DSM-IV-TR criteria for a primary mood disorder.
• •Severe obsessive-compulsive disorder (OCD), per children's yale-brown obsessive compulsive scale (CY-BOCS) score \>16.
• •Taken aripiprazole within 30 days of the Screening visit.
• •Received any investigational agent in a clinical trial within 30 days prior to Screening or who were randomized into a clinical trial with Once-weekly aripiprazole at any time.
• •History of neuroleptic malignant syndrome.
• •Sexually active participants not using 2 approved methods of contraception; breastfeeding or pregnant.
• •Risk of committing suicide
• •Bodyweight lower than 16 kg
• •Taken neuroleptic or antiparkinson drugs \<14 days prior to randomization.
• •Requiring cognitive-behavioral therapy (CBT) for TD during study.
• •Participant meets DSM-IV-TR criteria for any significant psychoactive substance use disorder within the past 3 months.
• •Positive drug screen
• •Participant requires medications not allowed per protocol
• •Use of CYP2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing and for duration of study.
• •Inability to swallow tablets or tolerate oral medication
• •Abnormal laboratory test results, vital signs and Electrocardiogram (ECG) results