Omega-3 Fatty Acids in Tourette's Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01315327|
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : July 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Tourette's Disorder||Drug: Omega-3 Fatty Acids Drug: Olive oil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 2003|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||May 2012|
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
- Yale Global Tic Severity Scale (YGTSS) [ Time Frame: 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.
- Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: Baseline and then weekly for 20 weeks ]Assesses type, frequency, and impairment of obsessions and compulsions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|