Clinical trial NCT01315327: Omega-3 Fatty Acids in Tourette's Disorder
Official title: A Double-Blind, Placebo-Controlled Study of Omega-3 Fatty Acids in Children and Adolescents With Tourette's Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourette's Disorder
Keywords: Tourette's Disorder, Obsessive-Compulsive Disorder, tics
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Tourette Association of America
First posted: 2011-03-15
Enrollment: 33
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: Baseline and then weekly for 20 weeks
Secondary outcomes:
measure: Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
timeFrame: Baseline and then weekly for 20 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Child Study Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Vilma Gabbay, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU School of Medicine
name: Barbara J Coffey, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gabbay V, Babb JS, Klein RG, Panzer AM, Katz Y, Alonso CM, Petkova E, Wang J, Coffey BJ. A double-blind, placebo-controlled trial of omega-3 fatty acids in Tourette's disorder. Pediatrics. 2012 Jun;129(6):e1493-500. doi: 10.1542/peds.2011-3384. Epub 2012 May 14.