Tourette's Disorder
Conditions
Keywords
Tourette's Disorder, Obsessive-Compulsive Disorder, tics
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.
Interventions
DRUGOmega-3 Fatty Acids
Omega-3 fatty acids (derived from fish oil)
DRUGOlive oil
Placebo
Sponsors
Tourette Association of America
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed