Status:
COMPLETED
Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder
Lead Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Chronic Motor or Vocal Tic Disorder
Tourette's Disorder
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00706589
Start Date
October 1 2008
End Date
April 1 2010
Last Update
July 26 2013
Active Locations (6)
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1
Inha University Hospital
Inchon, South Korea, 400-711
2
Seoul National University Hospital
Seoul, South Korea, 110-744
3
Yonsei University Severance Hospital
Seoul, South Korea, 120-752
4
Samsung Medical Center
Seoul, South Korea, 135-710