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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

NCT01727700

Tourette's Disorder Tic Disorder

COMPLETED PHASE3

Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

NCT01727713

Tourette's Disorder Tic Disorder

COMPLETED PHASE3

Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette's Syndrome

NCT03487783

Tourette Syndrome

COMPLETED PHASE3

Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder

NCT00241176

Tourette's Syndrome Tic Disorders

COMPLETED PHASE4

Aripiprazole in the Treatment of Tourette's Syndrome

NCT00282139

Tourette's Syndrome

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Motor or Vocal Tic Disorder Tourette's Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Aripiprazole 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)

Group Type EXPERIMENTAL

aripiprazole

Intervention Type DRUG

Initial dose : 2mg, Maximum dose : 20mg

2

Placebo 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Initial dose: 2mg, Maximum dose:20mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aripiprazole

Initial dose : 2mg, Maximum dose : 20mg

Intervention Type DRUG

placebo

Initial dose: 2mg, Maximum dose:20mg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Abilify

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No