Phase 3
Completed N=61
Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder
Chronic Motor or Vocal Tic Disorder · Tourette's Disorder
Source: ClinicalTrials.gov NCT00706589 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7) — -9.62; -14.97 units on a scale
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7) |
-9.62; -14.97 | — |
| SECONDARY 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. |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00706589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.