Omega-3 Fatty Acids in Tourette's Disorder

Tourette's Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315327
• Other study ID #: TSA Omega-3
• Status: Completed
• Phase: N/A
• First received: March 11, 2011
• Last updated: June 30, 2014
• Start date: May 2003
• Est. completion date: May 2012

Study information

• Verified date: June 2014
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2012
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tourette Syndrome
• Tourette's Disorder

Intervention

Drug:
• Omega-3 Fatty Acids
Omega-3 fatty acids (derived from fish oil)
• Olive oil
Placebo

Locations

Country	Name	City	State
United States	NYU Child Study Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Tourette Association of America

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 ?-3 fatty acids in Tourette's disorder. Pediatrics. 2012 Jun;129(6):e1493-500. doi: 10.1542/peds.2011-3384. Epub 2012 May — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No