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

Primary Purpose

Chronic Motor or Vocal Tic Disorder, Tourette's Disorder

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
aripiprazole
placebo
Sponsored by
Korea Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Motor or Vocal Tic Disorder focused on measuring Chronic Motor Tic disorder, Chronic Phonic Tic disorder, Tourette's disorder, Aripiprazole, Abilify, Children, Adolescent

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inha University Hospital
  • Seoul National University Hospital
  • Yonsei University Severance Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Chung-Ang Univ. Medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Aripiprazole 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)

Placebo 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 25, 2008
Last Updated
June 19, 2013
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00706589
Brief Title
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

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
Collaborators
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Aripiprazole 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)
Intervention Type
Drug
Intervention Name(s)
aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Initial dose : 2mg, Maximum dose : 20mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Initial dose: 2mg, Maximum dose:20mg
Primary Outcome Measure Information:
Title
Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)
Description
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.
Time Frame
10 week
Secondary Outcome Measure Information:
Title
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soochurl Cho, MD. Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inha University Hospital
City
Inchon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Chung-Ang Univ. Medical center
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24021518
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.
Results Reference
derived

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

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