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.
|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|
- 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.
- 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
|Study Start Date:||May 2003|
|Study Completion Date:||May 2012|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
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
This is a 20-week, double-blind, placebo (olive oil) controlled study examining supplemental fish oil in the treatment of tic and OCD symptoms.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315327
|United States, New York|
|NYU Child Study Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Vilma Gabbay, MD, MS||NYU School of Medicine|
|Principal Investigator:||Barbara J Coffey, MD, MS||NYU School of Medicine|