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

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Otsuka

Status and phase

Completed
Phase 3

Conditions

Tourette's Disorder
Chronic Motor or Vocal Tic Disorder

Treatments

Drug: aripiprazole
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00706589
031-KOA-0703

Details and patient eligibility

About

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

Enrollment

61 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

61 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Aripiprazole 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)
Treatment:
Drug: aripiprazole
2
Placebo Comparator group
Description:
Placebo 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)
Treatment:
Drug: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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