Omega-3 Fatty Acids in Tourette's Disorder

NYU Langone Health (Other)
Overall Status
Completed ID
Tourette Association of America (Other)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Omega-3 Fatty Acids
  • Drug: Olive oil

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 Design

Study Type:
Actual Enrollment :
33 participants
Intervention Model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Official Title:
A Double-Blind, Placebo-Controlled Study of Omega-3 Fatty Acids in Children and Adolescents With Tourette's Disorder
Study Start Date :
May 1, 2003
Actual Primary Completion Date :
Feb 1, 2006
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Yale Global Tic Severity Scale (YGTSS) [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.

Secondary Outcome Measures

  1. Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [Baseline and then weekly for 20 weeks]

    Assesses type, frequency, and impairment of obsessions and compulsions

Eligibility Criteria


Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 NYU Child Study Center New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • Tourette Association of America


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
NYU Langone Health Identifier:
Other Study ID Numbers:
  • TSA Omega-3
First Posted:
Mar 15, 2011
Last Update Posted:
Jul 1, 2014
Last Verified:
Jun 1, 2014
Keywords provided by NYU Langone Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2014