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.
|Condition or Disease||Intervention/Treatment||Phase|
This is a 20-week, double-blind, placebo (olive oil) controlled study examining supplemental fish oil in the treatment of tic and OCD symptoms.
Arms and 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
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
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.
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
|1||NYU Child Study Center||New York||New York||United States||10016|
Sponsors and Collaborators
- NYU Langone Health
- Tourette Association of America
- 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.
- TSA Omega-3