NCT01315327

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

2.8 years

First QC Date

March 11, 2011

Last Update Submit

June 30, 2014

Conditions

Tourette's Disorder

Keywords

Tourette's Disorder, Obsessive-Compulsive Disorder, tics

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

    Baseline and then weekly for 20 weeks

Study Arms (2)

Omega-3 Fatty Acids

EXPERIMENTAL

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

Drug: Omega-3 Fatty Acids

Placebo

PLACEBO COMPARATOR

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

Drug: Olive oil

Interventions

Omega-3 Fatty AcidsDRUG

Omega-3 fatty acids (derived from fish oil)

Omega-3 Fatty Acids
Olive oilDRUG

Placebo

Placebo

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Child Study Center

New York, New York, 10016, United States

Location

Related 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 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.

    PMID: 22585765RESULT

MeSH Terms

Conditions

Tourette SyndromeObsessive-Compulsive DisorderTics

Interventions

Fatty Acids, Omega-3Olive Oil

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersAnxiety DisordersDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Vilma Gabbay, MD, MS

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

  • Barbara J Coffey, MD, MS

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 15, 2011

Study Start

May 1, 2003

Primary Completion

February 1, 2006

Study Completion

May 1, 2012

Last Updated

July 1, 2014

Record last verified: 2014-06

Locations

US(1)