Major DepressionPhase 2/3NCT01803711

Omega 3 FA Supplements as Augmentation in the Treatment of Depression

A Phase 2/3 study testing Desvenlafaxine and Omega 3 Fatty acids in people with Major Depression and Cancer, run by UConn Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To assess the efficacy of Omega 3 Fatty acid (Omega 3 FA) augmentation of desvenlafaxine (DVS) compared to placebo augmentation of DVS when used to treat depression and anxiety symptoms in patients with select medical conditions (cancer, cardiovascular diseases and diabetes). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Major Depression, Cancer, Diabetes
What is being tested?: Desvenlafaxine and Omega 3 Fatty acids
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Feb 2013to Jun 2016
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years of age or older
Diagnosed with depression and have cardiovascular disease, diabetes or cancer.
Able to provide written informed consent prior to initiation of any study-related procedures.
Able to understand and comply with the requirements of the study.

Who cannot join

Hospitalized patients or psychotherapy for depression begun within 4 weeks.
Patients with medically reversible causes of depression (e.g. hypothyroidism).
Patients with significant comorbid symptoms (e.g. pain, insomnia) that have a direct causal relation to depressive and anxiety symptoms with these comorbid symptoms dominating the clinical scenario. Patients will be enrolled in the study if these comorbid symptoms merely coexist with depressive and anxiety symptoms and are not dominating the clinical scenario as judged by the study investigator
Patients with an identifiable diagnosis of substance abuse or dependence within 6 months prior to evaluation (except those in full remission, or those with caffeine or nicotine dependence) as defined by DSM-IV criteria.
Patients with any clinically significant unstable or inadequately treated co-morbid medical condition which, in the opinion of the investigator, would make the patient unsuited for the study
Patients with currently active or with significant history of other clinically significant psychiatric disorders such as bipolar disorder, schizophrenia etc.
Pregnant patients, breastfeeding or those planning to become pregnant during the study.
Any other condition, which, in the opinion of the investigator, would make the patient, unsuited for enrollment in the study, including known or suspect history of allergy to fish oil, fish or desvenlafaxine.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Connecticut Health Center
Farmington, Connecticut, 06030

Other trials in United States

About this study

Official title: A Randomized, Double-Blind Placebo-controlled Study Evaluating the Efficacy of Omega 3 Fatty Acid Augmentation of Desvenlafaxine for the Treatment of Major Depressive Disorder in Patients With Medical Illness.

Conditions: Major Depression, Cancer, Diabetes, Cardiovascular Diseases
Being tested: Desvenlafaxine, Omega 3 Fatty acids, Placebo (for Omega 3 fatty acid supplement)
Keywords: Omega 3 fatty acid, Fish oil, Depression, cancer, diabetes, high blood pressure, cardiovascular
Medical subject headings: Depressive Disorder, Major, Neoplasms, Diabetes Mellitus, Cardiovascular Diseases, Depression, Hypertension

What participants receive

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

DesvenlafaxineDrug
Also called Pristiq
Omega 3 Fatty acidsDietary supplement
Placebo (for Omega 3 fatty acid supplement)Drug

Study groups in NCT01803711
Study group	Role	What they receive
Desvenlafaxine + Omega 3 FA supplement	Experimental	Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period Receives: Drug: Desvenlafaxine; Dietary Supplement: Omega 3 Fatty acids
Desvenlafaxine + Placebo (for Omega 3 FA supplement)	Active comparator	Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period Receives: Drug: Desvenlafaxine; Drug: Placebo (for Omega 3 fatty acid supplement)

What is being measured

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

Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.
Measured: 12 weeks from baseline

Secondary outcomes (5)

Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: 12 weeks from baseline
Short Form Health Survey (SF-12)
Measured: 12 weeks from baseline
Visual Analog Scale for Energy (VAS-E)
Measured: 12 weeks from baseline
Visual Analog Scale for Pain (VAS-P)
Measured: 12 weeks from baseline
Leeds Sleep Evaluation Questionnaire (LSEQ)
Measured: 12 weeks from baseline

Timeline

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

Feb 2013Jun 2016

First posted4 Mar 2013 (estimated)
Study startFeb 2013
Primary completionJun 2016
Study completionJun 2016

Why it stopped: Lack of recruitment and no resources

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major DepressionStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01803711
Sponsor's protocol ID: OmegaDVS
Status last verified: Nov 2017
First submitted: 28 Feb 2013
Last updated: 27 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 Major Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind Placebo-controlled Study Evaluating the Efficacy of Omega 3 Fatty Acid Augmentation of Desvenlafaxine for the Treatment of Major Depressive Disorder in Patients With Medical Illness.
ClinicalTrials.gov ID: NCT01803711
Acronym / sponsor ID: OmegaDVS
Conditions: Major Depression, Cancer, Diabetes, Cardiovascular Diseases
Keywords: Omega 3 fatty acid, Fish oil, Depression, cancer, diabetes, high blood pressure, cardiovascular
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of recruitment and no resources
Enrolment: 6 participants (actual)
Lead sponsor: UConn HealthUniversity, hospital or other
Study start: Feb 2013
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 4 Mar 2013 (estimated)
Results: Posted 27 Dec 2017

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Desvenlafaxine + Omega 3 FA supplement	Experimental	Drug: Desvenlafaxine, Dietary Supplement: Omega 3 Fatty acidsDesvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period
Desvenlafaxine + Placebo (for Omega 3 FA supplement)	Active comparator	Drug: Desvenlafaxine, Drug: Placebo (for Omega 3 fatty acid supplement)Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period

Who may qualify

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

Key inclusion criteria (4 listed)

18 years of age or older
Diagnosed with depression and have cardiovascular disease, diabetes or cancer.
Able to provide written informed consent prior to initiation of any study-related procedures.
Able to understand and comply with the requirements of the study.

Key exclusion criteria (8 listed)

Hospitalized patients or psychotherapy for depression begun within 4 weeks.
Patients with medically reversible causes of depression (e.g. hypothyroidism).
Patients with significant comorbid symptoms (e.g. pain, insomnia) that have a direct causal relation to depressive and anxiety symptoms with these comorbid symptoms dominating the clinical scenario. Patients will be enrolled in the study if these comorbid symptoms merely coexist with depressive and anxiety symptoms and are not dominating the clinical scenario as judged by the study investigator
Patients with an identifiable diagnosis of substance abuse or dependence within 6 months prior to evaluation (except those in full remission, or those with caffeine or nicotine dependence) as defined by DSM-IV criteria.
Patients with any clinically significant unstable or inadequately treated co-morbid medical condition which, in the opinion of the investigator, would make the patient unsuited for the study

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
DesvenlafaxineAlso: Pristiq	Drug	Desvenlafaxine + Omega 3 FA supplement, Desvenlafaxine + Placebo (for Omega 3 FA supplement)
Omega 3 Fatty acids	Dietary supplement	Desvenlafaxine + Omega 3 FA supplement
Placebo (for Omega 3 fatty acid supplement)	Drug	Desvenlafaxine + Placebo (for Omega 3 FA supplement)

Primary outcome

Hospital Anxiety and Depression Scale
Time frame: 12 weeks from baseline
Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.

5 secondary outcomes

Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 12 weeks from baseline
Short Form Health Survey (SF-12)
Time frame: 12 weeks from baseline
Visual Analog Scale for Energy (VAS-E)
Time frame: 12 weeks from baseline
Visual Analog Scale for Pain (VAS-P)
Time frame: 12 weeks from baseline
Leeds Sleep Evaluation Questionnaire (LSEQ)
Time frame: 12 weeks from baseline

Results and safety

Results posted to the registry on 27 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Desvenlafaxine + Omega 3 FA Supplement	2	1
Desvenlafaxine + Placebo (for Omega 3 FA Supplement)	3	2

Primary outcome: Hospital Anxiety and Depression Scale

Time frame: 12 weeks from baseline

Population analysed: Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Desvenlafaxine + Omega 3 FA Supplement	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Desvenlafaxine + Placebo (for Omega 3 FA Supplement)	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Limitations and caveats (from the sponsor): Due to very low enrollment in both arms, only descriptive analyses was completed for both arms

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Jayesh Kamath, MD PhD principal investigator

UConn Health

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Desvenlafaxine and Omega 3 Fatty acids in people with Major Depression and Cancer, run by UConn Health at 1 site in United States.

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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 27 Dec 2017. 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 United States. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hospital Anxiety and Depression Scale (time frame: 12 weeks from baseline). 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 NCT01803711.

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 27 Dec 2017.