Aripiprazole in the Treatment of Tourette's Syndrome

NCT00282139 | Terminated

• 2 other identifiers: TSARIP703 / WIRB #2003137800040256/00042966
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette's Syndrome

Outcome Measures

Primary Outcomes (1)

• Global improvement in severity of symptoms (tic behaviors)

Secondary Outcomes (1)

• Assessment of behavior (improvement and severity) for co-morbid conditions, OCD and/or ADHD

Interventions

Aripiprazole DRUG

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Tourette Syndrome

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tanya K Murphy, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2006
• First Posted: January 25, 2006
• Study Start: January 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: October 5, 2011

Record last verified: 2011-10

Locations

US (1)