Omega-3 Fatty Acids in Tourette's Disorder

This study has been completed.
Sponsor:
Collaborator:
Tourette Syndrome Association
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01315327
First received: March 11, 2011
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Tourette's Disorder
Drug: Omega-3 Fatty Acids
Drug: Olive oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 33
Study Start Date: May 2003
Study Completion Date: May 2012
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315327

Locations
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 Syndrome Association
Investigators
Principal Investigator: Vilma Gabbay, MD, MS NYU School of Medicine
Principal Investigator: Barbara J Coffey, MD, MS NYU School of Medicine
  More Information

Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01315327     History of Changes
Other Study ID Numbers: TSA Omega-3
Study First Received: March 11, 2011
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Tourette Syndrome
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
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014