Aripiprazole in the Treatment of Tourette's Syndrome
Stopped early · Not applicable
Conditions studied: Tourette's Syndrome
In brief
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.
Key facts
- Study ID
- NCT00282139
- Run by
- University of Florida
- People needed
- 40
- Starts
- 2004-01-01
- Expected to finish
- 2006-10-01
- Last updated by the study team
- 2011-10-05
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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