An Open Label Trial of Omega 3(o3mega+Joy)in the Treatment of Social Phobia
NCT ID: NCT00485615
Last Updated: 2013-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
8 participants
INTERVENTIONAL
2008-10-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
OMEGA 3
Omega 3 Joy enteric coated concentrated fish oil
1500-3000mg; one per day
Interventions
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Omega 3 Joy enteric coated concentrated fish oil
1500-3000mg; one per day
Eligibility Criteria
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Inclusion 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
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.
18 Years
65 Years
ALL
No
Sponsors
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Genuine Health
INDUSTRY
START Clinic for Mood and Anxiety Disorders
OTHER
Responsible Party
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Dr. Martin A. Katzman
Principal Investigator
Principal Investigators
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Martin A. Katzman, MD
Role: PRINCIPAL_INVESTIGATOR
START Clinic for Mood and Anxiety Disorders
Locations
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START Clinic for Mood and Anxiety Disorders 900-790 Bay St.
Toronto, Ontario, Canada
Countries
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Other Identifiers
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GHOMEGA3SP
Identifier Type: -
Identifier Source: org_study_id