Clinical trial NCT00706589: Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Motor or Vocal Tic Disorder
Tourette's Disorder
Keywords: Chronic Motor Tic disorder
Chronic Phonic Tic disorder
Tourette's disorder
Aripiprazole
Abilify
Children
Adolescent
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2008-06-27
Enrollment: 61
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Male or female children and adolescents aged 6 to 18 years
3. 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.
4. The total tic score of the K-YGTSS (Korean version of Yale Global Tic Severity Scale)is more than 22 at baseline

Exclusion Criteria:

1. Patients with secondary tic symptoms accompanied by Tardive tics, Huntington disease, neuroacanthocytosis, mental retardation, or autism
2. Patients with IQ (Intelligence quotient) (assessed using KEDI-WISC (Korean educational Development Institute-Wechsler Intelligence Scale for children)) 70 and lower than 70
3. Patients with a history of neuroleptic malignant syndrome
4. Patients with antipsychotic or alcohol use disorder (abuse, dependence, and/or withdrawal) according to DSM-IV criteria for the past 3 months
5. Patients with a history of allergy or hypersensitivity reaction to aripiprazole
6. Patients with a history of resistance to treatment with antipsychotics
7. Patients who have participated in another clinical study within 1 month prior to screening
8. Patients who have previously taken aripiprazole or participated in a clinical study with aripiprazole

Primary outcomes:
measure: Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)
timeFrame: 10 week
Secondary outcomes:
measure: 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.
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Inchon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang Univ. Medical center
Study officials:
affiliation: Seoul National University Hospital
name: Soochurl Cho, MD. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoo HK, Joung YS, Lee JS, Song DH, Lee YS, Kim JW, Kim BN, Cho SC. A multicenter, randomized, double-blind, placebo-controlled study of aripiprazole in children and adolescents with Tourette's disorder. J Clin Psychiatry. 2013 Aug;74(8):e772-80. doi: 10.4088/JCP.12m08189.