Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder
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
1 other identifier
interventional
61
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2008
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2008
CompletedFirst Posted
Study publicly available on registry
June 27, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
July 26, 2013
CompletedJuly 26, 2013
June 1, 2013
1.5 years
June 25, 2008
January 27, 2011
June 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
1
EXPERIMENTALAripiprazole 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)
2
PLACEBO COMPARATORPlacebo 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Inha University Hospital
Inchon, 400-711, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Yonsei University Severance Hospital
Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Chung-Ang Univ. Medical center
Seoul, 156-755, South Korea
Related Publications (1)
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.
PMID: 24021518DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Kiho Moon
Study Officials
- PRINCIPAL INVESTIGATOR
Soochurl Cho, MD. Ph.D
Seoul National University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2008
First Posted
June 27, 2008
Study Start
October 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
July 26, 2013
Results First Posted
July 26, 2013
Record last verified: 2013-06