Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 21
Group description: Participants received aripiprazole 77.5 mg, tablet, orally once weekly for the 8-week Double-blind Treatment Period.
Eligibility criteria:
Inclusion Criteria:

7 to 17 year old with diagnostic and statistical manual of mental disorders, fourth edition -text revision (DSM-IV-TR) diagnostic criteria for Tourette's disorder (TD), confirmed by the kiddie schedule for affective disorders and schizophrenia - present and lifetime version (K-SADS-PL), including the Diagnostic Supplement 5
Has a total tic score (TTS) ≥20 on the yale global tic severity scale (YGTSS) at Screening and Baseline
Presenting tic symptoms cause impairment in the participant's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships
Females of childbearing potential must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception, and must not be pregnant or lactating.
Written informed consent form (ICF) obtained from a legally acceptable representative & informed assent at Screening as applicable by study center's Institutional review board/independent ethics committee (IRB/IEC)
The participant, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.

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