Omega-3 Fatty Acids in Tourette's Disorder

NYU Langone Health

Status: Completed

Conditions: Tourette's Disorder

Treatments: Drug: Olive oil; Drug: Omega-3 Fatty Acids

Study type: Interventional

Funder types: Other

Identifiers

NCT01315327

TSA Omega-3

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups, including a placebo group

Omega-3 Fatty Acids

Experimental group

Description:

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

Treatment:

Drug: Omega-3 Fatty Acids

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Olive oil