Omega-3 Fatty Acids in Tourette's Disorder

June 30, 2014 updated by: NYU Langone Health

A Double-Blind, Placebo-Controlled Study of Omega-3 Fatty Acids in Children and Adolescents With Tourette's Disorder

This study examines the safety and efficacy of omega-3 fatty acids (fish oil) for the treatment of Tourette's Disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Child Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega-3 Fatty Acids
Omega-3 Fatty Acids (fish oil), flexibly titrated up to 6000 mg/day.
Drug: Omega-3 Fatty Acids
Omega-3 fatty acids (derived from fish oil)
Placebo Comparator: Placebo
Olive oil placebo, looks and tastes identical to active intervention.
Drug: Olive oil
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yale Global Tic Severity Scale (YGTSS)
Time Frame: Baseline and then weekly for 20 weeks
This assessment captures tic type and frequency as well as intensity and complexity, and impairment due to tics.
Baseline and then weekly for 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time Frame: Baseline and then weekly for 20 weeks
Assesses type, frequency, and impairment of obsessions and compulsions
Baseline and then weekly for 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

Tourette Association of America

Investigators

  • Principal Investigator: Vilma Gabbay, MD, MS, NYU School of Medicine
  • Principal Investigator: Barbara J Coffey, MD, MS, NYU School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 11, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 30, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSA Omega-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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