Aripiprazole in the Treatment of Tourette's Syndrome

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00282139

Enrollment

Registered

2006-01-25

Start date

2004-01-31

Completion date

2006-10-31

Last updated

2011-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourette's Syndrome

Brief summary

This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms.

Detailed description

Interventions

DRUGAripiprazole

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Inclusion criteria

DSM-IV primary diagnosis of Tourette's syndrome or chronic tic disorder; Moderate severity as reflected on the CGI or the YGTSS; Normal ECG; and, Written informed consent/assent.

Exclusion criteria

Female subjects of childbearing potential who are not practicing an effective method of birth control (including abstinence); Subjects who are pregnant or nursing women; Subjects with known seizure disorder, a history or seizures or with conditions that lower seizure threshold; Subjects who currently meet DSM-IV criteria for: Schizophrenia, Schizoaffective Disorder, Delusional Disorder, or Psychotic Disorder Not Otherwise Specified; Subjects with a Psychoactive Substance Abuse disorder (within the past 3 months); Subjects with known allergy or hypersensitivity to aripiprazole; Subjects who have any depot neuroleptic within one treatment cycle or any other changes in psychoactive medications (with the exception of antidepressants) in one month and two months for antidepressants prior to study entry for first administration of study medication; Subjects who have clinically significant abnormalities based on physical examination, medical history, ECG, or laboratory tests; and, Subjects on medication that pose drug interaction potential with aripiprazole such as carbamazepine, ketoconazole, paroxetine, and fluoxetine.

Design outcomes

Primary

Measure	Time frame
Global improvement in severity of symptoms (tic behaviors)	—

Secondary

Measure	Time frame
Assessment of behavior (improvement and severity) for co-morbid conditions, OCD and/or ADHD	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026