Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder

Study Overview
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Brief Summary
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The purpose of this trial is to demonstrate the efficacy and safety of aripiprazole in children and adolescents aged 6 18 years with chronic tic disorders or Tourette's disorder

Official Title
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A Randomized, Double-blind, Dose-adjustment, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aripiprazole in Children and Adolescents With Chronic Tic Disorders or Tourette's Disorder

Conditions
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Chronic Motor or Vocal Tic Disorder, Tourette's Disorder

Intervention / Treatment
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* Drug: aripiprazole
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who can provide an assent form signed by themselves and informed consent form by their legal representatives prior to performing of any study procedures. Male or female children and adolescents aged 6 to 18 years Patients who are diagnosed with chronic tic disorders(Motor or Phonic) or Tourette's disorder according to DSM-IV(Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition)(using K-SADS-PL-K (Kiddle-Schedule for Affective Disorders and Schizophrenia,Present and Lifetime Version-Korean version)) and require drug therapy. The total tic score of the K-YGTSS (Korean version of Yale Global Tic Severity Scale)is more than 22 at baseline Exclusion Criteria: Patients with secondary tic symptoms accompanied by Tardive tics, Huntington disease, neuroacanthocytosis, mental retardation, or autism Patients with IQ (Intelligence quotient) (assessed using KEDI-WISC (Korean educational Development Institute-Wechsler Intelligence Scale for children)) 70 and lower than 70 Patients with a history of neuroleptic malignant syndrome Patients with antipsychotic or alcohol use disorder (abuse, dependence, and/or withdrawal) according to DSM-IV criteria for the past 3 months Patients with a history of allergy or hypersensitivity reaction to aripiprazole Patients with a history of resistance to treatment with antipsychotics Patients who have participated in another clinical study within 1 month prior to screening Patients who have previously taken aripiprazole or participated in a clinical study with aripiprazole

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Aripiprazole 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol) | Drug: aripiprazole<br>* Initial dose : 2mg, Maximum dose : 20mg<br>* Other names: Abilify;|
| Placebo Comparator: 2<br>Placebo 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol) | Drug: placebo<br>* Initial dose: 2mg, Maximum dose:20mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7) | The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result. | 10 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1)Percent Change of Total Tic Scores on the Korean Version of YaleGlobalTicseverity Scale.2)Response Rate Assessed With the Tic Score ClinicalGlobalImpressionImprovementScale.3)Mean Change in Scores on the Tic Score ClinicalGlobal ImpressionSeverityScale. |  | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Motor Tic disorder, Chronic Phonic Tic disorder, Tourette's disorder, Aripiprazole, Abilify, Children, Adolescent