An Open Label Trial of Omega 3(o3mega+Joy)in the Treatment of Social Phobia (OMEGA3SP)

This study has been completed.
Sponsor:
Collaborator:
Genuine Health
Information provided by (Responsible Party):
Dr. Martin A. Katzman, START Clinic for Mood and Anxiety Disorders
ClinicalTrials.gov Identifier:
NCT00485615
First received: June 11, 2007
Last updated: October 29, 2013
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Social Anxiety Disorder
Drug: Omega 3 Joy enteric coated concentrated fish oil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Pilot Study Evaluating the Efficacy of Enteric-coated Eicosapentaenoic Acid (o3mega+Joy) in the Treatment of Social Phobia

Resource links provided by NLM:


Further study details as provided by START Clinic for Mood and Anxiety Disorders:

Primary Outcome Measures:
  • Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks. [ Time Frame: Pre treatment - Post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SPIN, SIAS,SPS, ASI, BDI, BAI, SDS, Euroquol, SF 36, BI/BAS, BTSQ, BPS, Niacin Flushing Challenge [ Time Frame: Post treatment - Pre Treatment ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: October 2008
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
OMEGA 3
Drug: Omega 3 Joy enteric coated concentrated fish oil
1500-3000mg; one per day

Detailed Description:

Subjects meeting criteria for Social Anxiety Disorder, will receive enteric-coated, eicosapentaenoic acid-concentrated fish oil (O3mega+Joy) for 12 weeks of treatment for social phobia. A secondary objective is to determine if treatment outcome is related to changes in plasma phospholipid essential fatty acid status, niacin skin flush and measures of lipid/protein change.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible for this trial are patients who meet all of the following criteria:

    1. The patient has provided signed informed consent.
    2. Outpatients aged 18-65 (extremes included).
    3. 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)).
    4. On the basis of a physical examination, medical history and basic laboratory screening, the patient is, in the investigators opinion, in a suitable condition.
    5. Willing and able to attend study appointments in the correct time windows.

      Exclusion Criteria:

  • Patients meeting one or more of the following criteria cannot be selected for inclusion:

    1. Any other axis I diagnosis that was a primary disorder in the previous six months.
    2. Continuation or commencement of formal psychotherapy.
    3. Alcohol or drug abuse as defined in the DSM IV within the last six months.
    4. Mania or hypomania as defined in the DSM IV.
    5. Current use of or commencement of antidepressant and anxiolytic medications.
    6. 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
    7. 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..
    8. Any psychotic disorder.
    9. Eating disorders as defined in the DSM IV.
    10. Mental retardation or other cognitive disorder.
    11. Clinical interpretation of apparent suicide risk.
    12. Previous treatment efforts using 4000mg or more of fish oil daily.
    13. Current use of or commencement of essential fatty acid supplementation.
    14. Significant alterations from Standard North American Diet ie any special diets either restrictive of or inclusive of typical carbohydrate, protein and fat intake.
    15. Known sensitivity to fish oil or fish products.
    16. Any disorder of clotting or current use of warfarin.
    17. Laboratory values at screening or in medical history that may be considered through clinical interpretation to be significant.
    18. Diseases which could, through clinical interpretation, interfere with the assessments of safety, tolerability and efficacy.
    19. Serious illness: Liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolic disturbance.
    20. The patient is, in the opinion of the investigator, unlikely to be able to comply with the clinical trial protocol, or is unsuitable for any other reasons.
    21. Pregnant and breastfeeding females
    22. Females of childbearing years who do not use contraception.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485615

Locations
Canada, Ontario
START Clinic for Mood and Anxiety Disorders 900-790 Bay St.
Toronto,, Ontario, Canada, M4W 2N4
Sponsors and Collaborators
START Clinic for Mood and Anxiety Disorders
Genuine Health
Investigators
Principal Investigator: Martin A. Katzman, MD START Clinic for Mood and Anxiety Disorders
  More Information

No publications provided

Responsible Party: Dr. Martin A. Katzman, Principal Investigator, START Clinic for Mood and Anxiety Disorders
ClinicalTrials.gov Identifier: NCT00485615     History of Changes
Other Study ID Numbers: GHOMEGA3SP
Study First Received: June 11, 2007
Last Updated: October 29, 2013
Health Authority: Canada: Health Canada

Keywords provided by START Clinic for Mood and Anxiety Disorders:
eicosapentaenoic acid
fish oil
Omega 3
Social Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014