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Omega-3 Fatty Acids in Tourette's Disorder

This study has been completed.
Sponsor:
Collaborator:
Tourette Syndrome Association
Information provided by (Responsible Party):
Vilma Gabbay, MD, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01315327
First received: March 11, 2011
Last updated: June 28, 2012
Last verified: June 2012
History of Changes

March 11, 2011
June 28, 2012
May 2003
February 2006   (final data collection date for primary outcome measure)
Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Baseline and then weekly for 20 weeks ] [ Designated as safety issue: No ]
This assessment captures tic type and frequency as well as intensity and complexity, and impairment due to tics.
Same as current
Complete list of historical versions of study NCT01315327 on ClinicalTrials.gov Archive Site
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: Baseline and then weekly for 20 weeks ] [ Designated as safety issue: No ]
Assesses type, frequency, and impairment of obsessions and compulsions
Same as current
Not Provided
Not Provided
 
Omega-3 Fatty Acids in Tourette's Disorder
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.

This is a 20-week, double-blind, placebo (olive oil) controlled study examining supplemental fish oil in the treatment of tic and OCD symptoms.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Tourette's Disorder
  • Drug: Omega-3 Fatty Acids
    Omega-3 fatty acids (derived from fish oil)
  • Drug: Olive oil
    Placebo
  • Experimental: Omega-3 Fatty Acids
    Omega-3 Fatty Acids (fish oil), flexibly titrated up to 6000 mg/day.
    Intervention: Drug: Omega-3 Fatty Acids
  • Placebo Comparator: Placebo
    Olive oil placebo, looks and tastes identical to active intervention.
    Intervention: Drug: Olive oil
Gabbay V, Babb JS, Klein RG, Panzer AM, Katz Y, Alonso CM, Petkova E, Wang J, Coffey BJ. A Double-Blind, Placebo-Controlled Trial of Omega-3 Fatty Acids in Tourette's Disorder. Pediatrics. 2012 Jun;129(6):e1493-500. Epub 2012 May 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
May 2012
February 2006   (final data collection date for primary outcome measure)

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.
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01315327
TSA Omega-3
Yes
Vilma Gabbay, MD, New York University School of Medicine
New York University School of Medicine
Tourette Syndrome Association
Principal Investigator: Vilma Gabbay, MD, MS NYU School of Medicine
Principal Investigator: Barbara J Coffey, MD, MS NYU School of Medicine
New York University School of Medicine
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP