An Open Label Trial of Omega 3(o3mega+Joy)in the Treatment of Social Phobia
Information source: START Clinic for Mood and Anxiety Disorders
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Social Anxiety Disorder
Intervention: Omega 3 Joy enteric coated concentrated fish oil (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: START Clinic for Mood and Anxiety Disorders Official(s) and/or principal investigator(s):
Martin A. Katzman, MD, Principal Investigator, Affiliation: START Clinic for Mood and Anxiety Disorders
Overall contact:
Martin A Katzman, MD, Phone: 416 598 9344, Email: mkatzman@startclinic.ca
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.
Clinical Details
Official title: An Open-label, Pilot Study Evaluating the Efficacy of Enteric-coated Eicosapentaenoic Acid (o3mega+Joy) in the Treatment of Social Phobia
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks.
Secondary outcome: SPIN, SIAS,SPS, ASI, BDI, BAI, SDS, Euroquol, SF 36, BI/BAS, BTSQ, BPS, Niacin Flushing Challenge
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Martin A Katzman, MD, Phone: 416 598 9344, Email: mkatzman@startclinic.ca
START Clinic for Mood and Anxiety Disorders 900-790 Bay St., Toronto,, Ontario M4W 2N4, Canada; Recruiting
Martin A Katzman, MD, Phone: 416 598 9344, Email: mkatzman@startclinic.ca
Additional Information
Starting date: October 2008
Last updated: July 28, 2011
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