Aripiprazole in the Treatment of Tourette's Syndrome

Tourette's Syndrome Clinical Trial

Official title:

Aripiprazole in the Treatment of Tourette's Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00282139
• Other study ID #: TSARIP703 / WIRB #20031378
• Secondary ID: 00040256/0004296
• Status: Terminated
• Phase: N/A
• First received: January 23, 2006
• Last updated: October 4, 2011
• Start date: January 2004
• Est. completion date: October 2006

Study information

• Verified date: October 2011
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome
• Tourette's Syndrome

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global improvement in severity of symptoms (tic behaviors)
Secondary	Assessment of behavior (improvement and severity) for co-morbid conditions, OCD and/or ADHD