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Completed

NCT Number: NCT00706589

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

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

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Key information

Conditions

Chronic Motor or Vocal Tic Disorder Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tic Disorders Tourette Syndrome Tourette's Disorder

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Inha University Hospital, Inchon, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aripiprazole

Drug

Initial dose : 2mg, Maximum dose : 20mg

Other names: Abilify

Placebo

Drug

Initial dose: 2mg, Maximum dose:20mg

Primary outcomes

  1. Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)

    Time frame: 10 week

    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 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.

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 27, 2008
Registry last updated
Jul 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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