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Omega-3 Fatty Acids in Tourette's Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01315327
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : July 1, 2014
Information provided by (Responsible Party):

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
Tourette's Disorder 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 : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 2003
Primary Completion Date : February 2006
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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) [ 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.

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315327

United States, New York
NYU Child Study Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
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
More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01315327     History of Changes
Other Study ID Numbers: TSA Omega-3
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014

Keywords provided by New York University School of Medicine:
Tourette's Disorder, Obsessive-Compulsive Disorder, tics

Additional relevant MeSH terms:
Tourette Syndrome
Pathologic Processes
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
Neurodevelopmental Disorders
Mental Disorders