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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Korea Otsuka Pharmaceutical Co.,Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00706589
First received: June 25, 2008
Last updated: October 22, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Chronic Motor Tic Disorder
Chronic Phonic Tic Disorder
Tourette's Disorder
Drug: aripiprazole
Drug: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:
  • Mean change in total tic scores on the K-YGTSS [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • (1)Percent change of total tic scores on the K-YGTSS. (2)Response rate assessed with the TS-CGI-Improvement scale. (3)Mean change in scores on the TS-CGI-Severity scale. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 56
Study Start Date: October 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aripiprazole
Drug: aripiprazole
Initial dose : 2mg, Maximum dose : 20mg
Other Name: Abilify
Placebo Comparator: 2
Placebo
Drug: placebo
2mg~20mg

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (using K-SADS-PL-K) and require drug therapy.
  4. The total tic score of the K-YGTSS 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 (assessed using KEDI-WISC) 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706589

Contacts
Contact: Pum-Soo Kim, MD. Ph.D 82-2-3472-9811 pumsoo.kim@otsuka.co.kr
Contact: MiRan Moon 82-2-3472-1311 mrmoon@otsuka.co.kr

Locations
Korea, Republic of
Inha University Hospital Not yet recruiting
Inchon, Korea, Republic of, 400-711
Contact: JeongSeop Lee, MD. Ph.D     82-32-890-3474     soulfree@inha.ac.kr    
Chung-Ang Univ. Medical center Not yet recruiting
Seoul, Korea, Republic of, 156-755
Contact: YoungSik Lee, MD. Ph.D     82-2-6299-1518     hawkeyelys@hanmail.net    
Yonsei University Severance Hospital Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: DongHo Song, MD. Ph.D     82-2-2228-1620     dhsong@yuhs.ac    
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 138-736
Contact: Hanik Yoo, MD. Ph.D     82-2-3010-3423     hiyoo@amc.seoul.kr    
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: YooSook Joung, MD. Ph.D     82-2-3410-3589     yschoung@skku.edu    
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: SooChurl Cho, MD. Ph.D     82-2-2072-2450     soochurl@snu.ac.kr    
Contact: Boong-Nyun Kim, MD. Ph.D     82-2-2072-3647     kbn1@snu.ac.kr    
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
Otsuka Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Soochurl Cho, MD. Ph.D Seoul National University Hospital
  More Information

No publications provided

Responsible Party: MiRan Moon/Clinical Resarch Manager, Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00706589     History of Changes
Other Study ID Numbers: 031-KOA-0703
Study First Received: June 25, 2008
Last Updated: October 22, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:
Chronic Motor Tic disorder
Chronic Phonic Tic disorder
Tourette's disorder
Aripiprazole
Abilify
Children
Adolescent

Additional relevant MeSH terms:
Tic Disorders
Tics
Tourette Syndrome
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013