efficacy & safety study of once-weekly oral aripiprazole in children and adolescents with tourette's disorder

Conditions: Tourette's Disorder

Summary: the goal of the current study is to determine efficacy and safety of once-weekly aripiprazole in reducing total tic severity (tts) score in children and adolescents with tourette's disorder.


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

Keywords: tourette's disorder tic disorders