NCT00485615

Brief Summary

The primary objective is to evaluate the efficacy of an enteric-coated, eicosapentaenoic acid-concentrated fish oil in the treatment of social phobia. A secondary objective is to determine if treatment outcome is related to plasma phospholipid essential fatty acid status, niacin skin flush and measures of lipid/protein peroxidation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_2

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

First Submitted

Initial submission to the registry

June 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2007

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 30, 2013

Status Verified

June 1, 2010

Enrollment Period

4.8 years

First QC Date

June 11, 2007

Last Update Submit

October 29, 2013

Conditions

Social Anxiety Disorder

Keywords

eicosapentaenoic acidfish oilOmega 3Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks.

    Pre treatment - Post treatment

Secondary Outcomes (1)

  • SPIN, SIAS,SPS, ASI, BDI, BAI, SDS, Euroquol, SF 36, BI/BAS, BTSQ, BPS, Niacin Flushing Challenge

    Post treatment - Pre Treatment

Study Arms (1)

1

EXPERIMENTAL

OMEGA 3

Drug: Omega 3 Joy enteric coated concentrated fish oil

Interventions

Omega 3 Joy enteric coated concentrated fish oilDRUG

1500-3000mg; one per day

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible for this trial are patients who meet all of the following criteria:
  • The patient has provided signed informed consent.
  • Outpatients aged 18-65 (extremes included).
  • Patients with a primary diagnosis of Social Phobia according to DSM IV (300.23) criteria (diagnosis to be made using the Mini International Neuropsychiatric Interview (MINI)).
  • On the basis of a physical examination, medical history and basic laboratory screening, the patient is, in the investigators opinion, in a suitable condition.
  • Willing and able to attend study appointments in the correct time windows.

You may not qualify if:

  • Any other axis I diagnosis that was a primary disorder in the previous six months.
  • Continuation or commencement of formal psychotherapy.
  • Alcohol or drug abuse as defined in the DSM IV within the last six months.
  • Mania or hypomania as defined in the DSM IV.
  • Current use of or commencement of antidepressant and anxiolytic medications.
  • Patients who have been on an antidepressant or other anxiolytic prior to the study, will have discontinued it more than two weeks prior to entry into the study. Those who have been on fluoxetine, will have been off of it for at least 5 weeks
  • Patients who have been on an herbal or alternative treatment judged to be potentially anxiolytic or with psychobiological activity, will have terminated usage of the agent more than two weeks prior to entering the study..
  • Any psychotic disorder.
  • Eating disorders as defined in the DSM IV.
  • Mental retardation or other cognitive disorder.
  • Clinical interpretation of apparent suicide risk.
  • Previous treatment efforts using 4000mg or more of fish oil daily.
  • Current use of or commencement of essential fatty acid supplementation.
  • Significant alterations from Standard North American Diet ie any special diets either restrictive of or inclusive of typical carbohydrate, protein and fat intake.
  • Known sensitivity to fish oil or fish products.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

START Clinic for Mood and Anxiety Disorders 900-790 Bay St.

Toronto, Ontario, M4W 2N4, Canada

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Martin A. Katzman, MD

    START Clinic for Mood and Anxiety Disorders

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 13, 2007

Study Start

October 1, 2008

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 30, 2013

Record last verified: 2010-06

Locations

CA(1)