Aripiprazole in the Treatment of Tourette's Syndrome

Sponsor

University of Florida (Other)

Overall Status

Terminated

CT.gov ID

NCT00282139

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tourette's Syndrome	Drug: Aripiprazole	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

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

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT00282139

Other Study ID Numbers:

TSARIP703 / WIRB #20031378
00040256/00042966

First Posted:

Jan 25, 2006

Last Update Posted:

Oct 5, 2011

Last Verified:

Oct 1, 2011

Additional relevant MeSH terms:

Tourette Syndrome

Syndrome

Aripiprazole

Study Results

No Results Posted as of Oct 5, 2011