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

Tourette's Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706589
• Other study ID #: 031-KOA-0703
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2008
• Last updated: June 19, 2013
• Start date: October 2008
• Est. completion date: April 2010

Study information

• Verified date: June 2013
• Source: Korea Otsuka Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Motor or Vocal Tic Disorder
• Disease
• Tic Disorders
• Tics
• Tourette Syndrome
• Tourette's Disorder

Intervention

Drug:
• aripiprazole
Initial dose : 2mg, Maximum dose : 20mg
• placebo
Initial dose: 2mg, Maximum dose:20mg

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Inchon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang Univ. Medical center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co.,Ltd.	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No