Omega-3 Fatty Acids in Tourette's Disorder

Not Applicable

Completed

• Conditions: Tourette's Disorder
• Interventions: Drug: Olive oil; Drug: Omega-3 Fatty Acids

• Registration Number: NCT01315327
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-05
• Primary Completion: 2006-02
• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-15
• Study Completion: 2012-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Olive oil	Olive oil placebo, looks and tastes identical to active intervention.
Omega-3 Fatty Acids	Omega-3 Fatty Acids	Omega-3 Fatty Acids (fish oil), flexibly titrated up to 6000 mg/day.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

NYU Child Study Center; 🇺🇸 New York, New York, United States