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Aripiprazole in the Treatment of Tourette's Syndrome

Primary Purpose

Tourette's Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
University of Florida
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette's Syndrome

Eligibility Criteria

6 Years - 17 Years (Child)All Sexes

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.

Sites / Locations

  • University of Florida

Outcomes

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

Full Information

First Posted
January 23, 2006
Last Updated
October 4, 2011
Sponsor
University of Florida
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00282139
Brief Title
Aripiprazole in the Treatment of Tourette's Syndrome
Official Title
Aripiprazole in the Treatment of Tourette's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Study Start Date
January 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Bristol-Myers Squibb

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette's Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Primary Outcome Measure Information:
Title
Global improvement in severity of symptoms (tic behaviors)
Secondary Outcome Measure Information:
Title
Assessment of behavior (improvement and severity) for co-morbid conditions, OCD and/or ADHD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya K Murphy, M.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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