Omega-3 Fatty Acids in Tourette’s Disorder

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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