Aripiprazole in the Treatment of Tourette's Syndrome
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Tourette's Syndrome |
Drug: Aripiprazole |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Aripiprazole in the Treatment of Tourette's Syndrome |
- Global improvement in severity of symptoms (tic behaviors)
- Assessment of behavior (improvement and severity) for co-morbid conditions, OCD and/or ADHD
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2004 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
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.
Contacts and Locations| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Principal Investigator: | Tanya K Murphy, M.D. | University of Florida |
More Information
No publications provided
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT00282139 History of Changes |
| Other Study ID Numbers: | TSARIP703 / WIRB #20031378, 00040256/00042966 |
| Study First Received: | January 23, 2006 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Tic Disorders Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Mental Disorders Diagnosed in Childhood |
Mental Disorders Aripiprazole Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 18, 2013