Social Anxiety DisorderPhase 2OMEGA3SPNCT00485615

An Open Label Trial of Omega 3(o3mega+Joy)in the Treatment of Social Phobia

A Phase 2 study testing Omega 3 Joy enteric coated concentrated fish oil in people with Social Anxiety Disorder, run by START Clinic for Mood and Anxiety Disorders at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Social Anxiety Disorder
What is being tested?: Omega 3 Joy enteric coated concentrated fish oil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteCanada
Study dates: Oct 2008to Aug 2013
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 23Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

START Clinic for Mood and Anxiety Disorders 900-790 Bay St.
Toronto, Ontario, M4W 2N4

Other trials in Canada

About this study

Official title: An Open-label, Pilot Study Evaluating the Efficacy of Enteric-coated Eicosapentaenoic Acid (o3mega+Joy) in the Treatment of Social Phobia

Read the 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.

Conditions: Social Anxiety Disorder
Being tested: Omega 3 Joy enteric coated concentrated fish oil
Keywords: eicosapentaenoic acid, fish oil, Omega 3, Social Anxiety Disorder
Medical subject headings: Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omega 3 Joy enteric coated concentrated fish oilDrug
1500-3000mg; one per day

Study groups in NCT00485615
Study group	Role	What they receive
1	Experimental	OMEGA 3 Receives: Drug: Omega 3 Joy enteric coated concentrated fish oil

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks.
Measured: Pre treatment - Post treatment

Secondary outcomes (1)

SPIN, SIAS,SPS, ASI, BDI, BAI, SDS, Euroquol, SF 36, BI/BAS, BTSQ, BPS, Niacin Flushing Challenge
Measured: Post treatment - Pre Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Aug 2013

First posted13 Jun 2007 (estimated)
Study startOct 2008
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00485615
Sponsor's protocol ID: GHOMEGA3SP
Acronym: OMEGA3SP
Status last verified: Jun 2010
First submitted: 11 Jun 2007
Last updated: 30 Oct 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Social Anxiety Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Pilot Study Evaluating the Efficacy of Enteric-coated Eicosapentaenoic Acid (o3mega+Joy) in the Treatment of Social Phobia
ClinicalTrials.gov ID: NCT00485615
Acronym / sponsor ID: OMEGA3SP / GHOMEGA3SP
Conditions: Social Anxiety Disorder
Keywords: eicosapentaenoic acid, fish oil, Omega 3, Social Anxiety Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: START Clinic for Mood and Anxiety DisordersUniversity, hospital or other
Collaborators: Genuine Health
Study start: Oct 2008
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 13 Jun 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Omega 3 Joy enteric coated concentrated fish oilOMEGA 3

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Eligible for this trial are patients who meet all of the following criteria:

Key exclusion criteria (23 listed)

Patients meeting one or more of the following criteria cannot be selected for inclusion:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omega 3 Joy enteric coated concentrated fish oil1500-3000mg; one per day	Drug	1

Primary outcome

Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks.
Time frame: Pre treatment - Post treatment

1 secondary outcome

SPIN, SIAS,SPS, ASI, BDI, BAI, SDS, Euroquol, SF 36, BI/BAS, BTSQ, BPS, Niacin Flushing Challenge
Time frame: Post treatment - Pre Treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.

Related trials for Social Anxiety Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Not yet recruiting
Online Study on the Impact of a Self-Help Tool for Social Anxiety
Social Anxiety
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martin A. Katzman, MD principal investigator

START Clinic for Mood and Anxiety Disorders

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omega 3 Joy enteric coated concentrated fish oil in people with Social Anxiety Disorder, run by START Clinic for Mood and Anxiety Disorders at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks. (time frame: Pre treatment - Post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00485615.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.