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Aripiprazole in the Treatment of Tourette's Syndrome

This study has been terminated.
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Florida Identifier:
First received: January 23, 2006
Last updated: October 4, 2011
Last verified: October 2011
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
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aripiprazole in the Treatment of Tourette's Syndrome

Resource links provided by NLM:

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Global improvement in severity of symptoms (tic behaviors)

Secondary Outcome Measures:
  • 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)
Detailed Description:
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.

Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All

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
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Please refer to this study by its identifier: NCT00282139

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Bristol-Myers Squibb
Principal Investigator: Tanya K Murphy, M.D. University of Florida
  More Information

Responsible Party: University of Florida Identifier: NCT00282139     History of Changes
Other Study ID Numbers: TSARIP703 / WIRB #20031378
Study First Received: January 23, 2006
Last Updated: October 4, 2011

Additional relevant MeSH terms:
Tourette Syndrome
Pathologic Processes
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
Neurodevelopmental Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 24, 2017