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Completed

NCT Number: NCT01315327

Omega-3 Fatty Acids in Tourette's Disorder

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

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Key information

About this study

This is a 20-week, double-blind, placebo (olive oil) controlled study examining supplemental fish oil in the treatment of tic and OCD symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3 Fatty acids

Drug

Omega-3 fatty acids (derived from fish oil)

Olive Oil

Drug

Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Tourette Association of America

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2012
First posted
Mar 15, 2011
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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