Omega-3 Fatty Acids in Tourette's Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2012-05-31

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.

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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.

Conditions

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Tourette's Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omega-3 Fatty Acids

Omega-3 Fatty Acids (fish oil), flexibly titrated up to 6000 mg/day.

Group Type EXPERIMENTAL

Omega-3 Fatty Acids

Intervention Type DRUG

Omega-3 fatty acids (derived from fish oil)

Placebo

Olive oil placebo, looks and tastes identical to active intervention.

Group Type PLACEBO_COMPARATOR

Olive oil

Intervention Type DRUG

Placebo

Interventions

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Omega-3 Fatty Acids

Omega-3 fatty acids (derived from fish oil)

Intervention Type DRUG

Olive oil

Placebo

Intervention Type DRUG

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No