Omega-3 Fatty Acids in Tourette's Disorder

Study Overview
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Brief Summary
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This study examines the safety and efficacy of omega-3 fatty acids (fish oil) for the treatment of Tourette's Disorder.

Detailed Description
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This is a 20-week, double-blind, placebo (olive oil) controlled study examining supplemental fish oil in the treatment of tic and OCD symptoms.

Official Title
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A Double-Blind, Placebo-Controlled Study of Omega-3 Fatty Acids in Children and Adolescents With Tourette's Disorder

Conditions
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Tourette's Disorder

Intervention / Treatment
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* Drug: Omega-3 Fatty Acids
* Drug: Olive oil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 Fatty Acids<br>Omega-3 Fatty Acids (fish oil), flexibly titrated up to 6000 mg/day. | Drug: Omega-3 Fatty Acids<br>* Omega-3 fatty acids (derived from fish oil)<br>|
| Placebo Comparator: Placebo<br>Olive oil placebo, looks and tastes identical to active intervention. | Drug: Olive oil<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Global Tic Severity Scale (YGTSS) | This assessment captures tic type and frequency as well as intensity and complexity, and impairment due to tics. | Baseline and then weekly for 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | Assesses type, frequency, and impairment of obsessions and compulsions | Baseline and then weekly for 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tourette's Disorder, Obsessive-Compulsive Disorder, tics