Omega-3 Fatty Acids in Tourette's Disorder

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT01315327

Collaborator

Tourette Association of America (Other)

Enrollment

Location

Arms

108

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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	Phase
Tourette's Disorder	Drug: Omega-3 Fatty Acids Drug: Olive oil	N/A

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

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 1, 2003

Actual Primary Completion Date :

Feb 1, 2006

Actual Study Completion Date :

May 1, 2012

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 Placebo

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

Placebo

Outcome Measures

Primary Outcome Measures

Yale Global Tic Severity Scale (YGTSS) [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

Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [Baseline and then weekly for 20 weeks]
Assesses type, frequency, and impairment of obsessions and compulsions

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	NYU Child Study Center	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health
Tourette Association of America

Investigators

Principal Investigator: Vilma Gabbay, MD, MS, NYU School of Medicine
Principal Investigator: Barbara J Coffey, MD, MS, NYU School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT01315327

Other Study ID Numbers:

TSA Omega-3

First Posted:

Mar 15, 2011

Last Update Posted:

Jul 1, 2014

Last Verified:

Jun 1, 2014

Keywords provided by NYU Langone Health

Tourette's Disorder, Obsessive-Compulsive Disorder, tics

Additional relevant MeSH terms:

Tourette Syndrome

Disease

Study Results

No Results Posted as of Jul 1, 2014