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| Name | Class |
|---|---|
| Genuine Health | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | OMEGA 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3 Joy enteric coated concentrated fish oil | Drug | 1500-3000mg; one per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks. | Pre treatment - Post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| SPIN, SIAS,SPS, ASI, BDI, BAI, SDS, Euroquol, SF 36, BI/BAS, BTSQ, BPS, Niacin Flushing Challenge | Post treatment - Pre Treatment |
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Inclusion Criteria:
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.
Exclusion Criteria:
Patients meeting one or more of the following criteria cannot be selected for inclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Martin A. Katzman, MD | START Clinic for Mood and Anxiety Disorders | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| START Clinic for Mood and Anxiety Disorders 900-790 Bay St. | Toronto | Ontario | M4W 2N4 | Canada |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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