- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00485615
An Open Label Trial of Omega 3(o3mega+Joy)in the Treatment of Social Phobia (OMEGA3SP)
October 29, 2013 updated by: Dr. Martin A. Katzman, START Clinic for Mood and Anxiety Disorders
An Open-label, Pilot Study Evaluating the Efficacy of Enteric-coated Eicosapentaenoic Acid (o3mega+Joy) in the Treatment of Social Phobia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto,, Ontario, Canada, M4W 2N4
- START Clinic for Mood and Anxiety Disorders 900-790 Bay St.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- Any other axis I diagnosis that was a primary disorder in the previous six months.
- Continuation or commencement of formal psychotherapy.
- Alcohol or drug abuse as defined in the DSM IV within the last six months.
- Mania or hypomania as defined in the DSM IV.
- Current use of or commencement of antidepressant and anxiolytic medications.
- 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
- 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..
- Any psychotic disorder.
- Eating disorders as defined in the DSM IV.
- Mental retardation or other cognitive disorder.
- Clinical interpretation of apparent suicide risk.
- Previous treatment efforts using 4000mg or more of fish oil daily.
- Current use of or commencement of essential fatty acid supplementation.
- Significant alterations from Standard North American Diet ie any special diets either restrictive of or inclusive of typical carbohydrate, protein and fat intake.
- Known sensitivity to fish oil or fish products.
- Any disorder of clotting or current use of warfarin.
- Laboratory values at screening or in medical history that may be considered through clinical interpretation to be significant.
- Diseases which could, through clinical interpretation, interfere with the assessments of safety, tolerability and efficacy.
- Serious illness: Liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolic disturbance.
- 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.
- Pregnant and breastfeeding females
- Females of childbearing years who do not use contraception.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
OMEGA 3
|
1500-3000mg; one per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks.
Time Frame: Pre treatment - Post treatment
|
Pre treatment - Post treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SPIN, SIAS,SPS, ASI, BDI, BAI, SDS, Euroquol, SF 36, BI/BAS, BTSQ, BPS, Niacin Flushing Challenge
Time Frame: Post treatment - Pre Treatment
|
Post treatment - Pre Treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Martin A. Katzman, MD, START Clinic for Mood and Anxiety Disorders
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (ACTUAL)
August 1, 2013
Study Completion (ACTUAL)
August 1, 2013
Study Registration Dates
First Submitted
June 11, 2007
First Submitted That Met QC Criteria
June 11, 2007
First Posted (ESTIMATE)
June 13, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
October 30, 2013
Last Update Submitted That Met QC Criteria
October 29, 2013
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GHOMEGA3SP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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