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Sponsors and Collaborators: |
START Clinic for Mood and Anxiety Disorders Genuine Health |
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Information provided by: | START Clinic for Mood and Anxiety Disorders |
ClinicalTrials.gov Identifier: | NCT00485615 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Open-Label, Pilot Study Evaluating the Efficacy of Enteric-Coated Eicosapentaenoic Acid (o3mega+Joy) in the Treatment of Social Phobia |
Estimated Enrollment: | 50 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
OMEGA 3
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Drug: Omega 3 Joy enteric coated concentrated fish oil |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible for this trial are patients who meet all of the following criteria:
Exclusion Criteria:
Patients meeting one or more of the following criteria cannot be selected for inclusion:
Contact: Martin A Katzman, MD | 416 598 9344 | mkatzman@startclinic.ca |
Canada, Ontario | |
START Clinic for Mood and Anxiety Disorders 900-790 Bay St. | |
Toronto,, Ontario, Canada, M5G 1N8 |
Principal Investigator: | Martin A. Katzman, MD | START Clinic for Mood and Anxiety Disorders |
Responsible Party: | START clinic for Mood and Anxiety Disorders ( Dr. M. Katzman ) |
Study ID Numbers: | GHOMEGA3SP |
Study First Received: | June 11, 2007 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00485615 History of Changes |
Health Authority: | Canada: Health Canada |
eicosapentaenoic acid fish oil Omega 3 Social Anxiety Disorder |
Anxiety Disorders Mental Disorders Phobic Disorders |
Anxiety Disorders Mental Disorders Phobic Disorders |