Brief Title
Omega-3 Fatty Acids in Tourette's Disorder
Official Title
A Double-Blind, Placebo-Controlled Study of Omega-3 Fatty Acids in Children and Adolescents With Tourette's Disorder
Brief Summary
This study examines the safety and efficacy of omega-3 fatty acids (fish oil) for the treatment of Tourette's Disorder.
Detailed Description
This is a 20-week, double-blind, placebo (olive oil) controlled study examining supplemental fish oil in the treatment of tic and OCD symptoms.
Study Type
Interventional
Primary Outcome
Yale Global Tic Severity Scale (YGTSS)
Secondary Outcome
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Condition
Tourette's Disorder
Intervention
Omega-3 Fatty Acids
Study Arms / Comparison Groups
Omega-3 Fatty Acids
Description: Omega-3 Fatty Acids (fish oil), flexibly titrated up to 6000 mg/day.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
33
Start Date
May 2003
Completion Date
May 2012
Primary Completion Date
February 2006
Eligibility Criteria
Inclusion Criteria: - Ages 6 through 18 inclusive - Meet full DSM-IV diagnostic criteria for TD or chronic motor tic disorder - Normal laboratory results, including serum chemistries, hematology, and urinalysis - Must be able to swallow capsules. - Must be of normal intelligence in the judgment of the investigator. - Subjects and parents must possess an educational level, degree of understanding and command of the English language to enable them to communicate suitably with the investigator and study coordinator and to understand the nature of the study. - Subjects and their legal representatives must be considered reliable. Exclusion Criteria: - Organic brain disease, for example, traumatic brain injury residua - Meeting criteria for mental retardation as defined by the DSM-IV. - A history of seizure disorder (other than febrile seizure). - A Subjects with history of Sydenham's Chorea. - Autism, schizophrenia or other psychotic disorders. - A primary diagnosis of a major mood disorder that requires ongoing psychiatric treatment. - A neurological disorder other than a tic disorder. - A documented auto-immune disorder. - A major medical illness. - A history of ongoing or previously undisclosed child abuse (risk of removal from home would not allow for consistent caretaker ratings). - Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study.
Gender
All
Ages
6 Years - 18 Years
Accepts Healthy Volunteers
No
Contacts
Vilma Gabbay, MD, MS, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01315327
Organization ID
TSA Omega-3
Responsible Party
Sponsor
Study Sponsor
NYU Langone Health
Collaborators
Tourette Association of America
Study Sponsor
Vilma Gabbay, MD, MS, Principal Investigator, NYU School of Medicine
Verification Date
June 2014