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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. Identifier: NCT01315327
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : July 1, 2014
Tourette Association of America
Information provided by (Responsible Party):
NYU Langone Health

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
Tourette's Disorder Drug: Omega-3 Fatty Acids Drug: Olive oil Not Applicable

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.

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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
Actual Primary Completion Date : February 2006
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT01315327

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United States, New York
NYU Child Study Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Tourette Association of America
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Principal Investigator: Vilma Gabbay, MD, MS NYU School of Medicine
Principal Investigator: Barbara J Coffey, MD, MS NYU School of Medicine

Publications of Results:
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Responsible Party: NYU Langone Health 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 NYU Langone Health:
Tourette's Disorder, Obsessive-Compulsive Disorder, tics
Additional relevant MeSH terms:
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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
Tourette Syndrome
Pathologic Processes