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Omega-3 Fatty Acids in Tourette's Disorder

Primary Purpose

Tourette's Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 Fatty Acids
Olive oil
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette's Disorder focused on measuring Tourette's Disorder, Obsessive-Compulsive Disorder, tics

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • NYU Child Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega-3 Fatty Acids

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Yale Global Tic Severity Scale (YGTSS)
This assessment captures tic type and frequency as well as intensity and complexity, and impairment due to tics.

Secondary Outcome Measures

Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Assesses type, frequency, and impairment of obsessions and compulsions

Full Information

First Posted
March 11, 2011
Last Updated
June 30, 2014
Sponsor
NYU Langone Health
Collaborators
Tourette Association of America
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1. Study Identification

Unique Protocol Identification Number
NCT01315327
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Tourette Association of America

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette's Disorder
Keywords
Tourette's Disorder, Obsessive-Compulsive Disorder, tics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 Fatty Acids
Arm Type
Experimental
Arm Description
Omega-3 Fatty Acids (fish oil), flexibly titrated up to 6000 mg/day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Olive oil placebo, looks and tastes identical to active intervention.
Intervention Type
Drug
Intervention Name(s)
Omega-3 Fatty Acids
Intervention Description
Omega-3 fatty acids (derived from fish oil)
Intervention Type
Drug
Intervention Name(s)
Olive oil
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Yale Global Tic Severity Scale (YGTSS)
Description
This assessment captures tic type and frequency as well as intensity and complexity, and impairment due to tics.
Time Frame
Baseline and then weekly for 20 weeks
Secondary Outcome Measure Information:
Title
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Description
Assesses type, frequency, and impairment of obsessions and compulsions
Time Frame
Baseline and then weekly for 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilma Gabbay, MD, MS
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara J Coffey, MD, MS
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Child Study Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22585765
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.
Results Reference
result

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Omega-3 Fatty Acids in Tourette's Disorder

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