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

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

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