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Aripiprazole in the Treatment of Tourette's Syndrome

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282139
First Posted: January 25, 2006
Last Update Posted: October 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Florida
  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
Intervention Model: Single Group Assignment
Masking: None (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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282139


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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00282139     History of Changes
Other Study ID Numbers: TSARIP703 / WIRB #20031378
00040256/00042966
First Submitted: January 23, 2006
First Posted: January 25, 2006
Last Update Posted: October 5, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Syndrome
Tourette Syndrome
Disease
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
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs