DepressionPhase 2Omega-3(2)NCT02021669
Omega-3 for Depression and Other Cardiac Risk Factors - 2
A Phase 2 study testing Omega-3 supplement in people with Depression, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to determine whether antidepressant augmentation with two grams of EPA omega-3 per day is superior to antidepressant therapy alone for major depression in patients with coronary heart disease (CHD). Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Omega-3 supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2014to 13 Sep 2018
- Phase
- Phase 2
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented coronary heart disease
- Diagnosis of major depression based on structured interview
Who cannot join
- Moderate to severe cognitive impairment
- Meets DSM-5 criteria for depressive disorder due to a general medical condition or medication
- Major Axis I psychiatric disorder other than unipolar depression or an anxiety disorder, a high risk of suicide, or current substance abuse other than tobacco;
- Not expected to survive one year or physically unable to tolerate the study protocol
- Known sensitivity to sertraline or omega-3, or an allergy to fish oil or shellfish
- Taking an antidepressant or an omega-3 supplement at baseline
Show all 9Show fewer
- Exempted by their cardiologist or primary care physician
- Refuses to provide informed consent
- Participating in a competing protocol or trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Medical Center
St Louis, Missouri, 63108
About this study
Official title: Omega-3 for Depression and Other Cardiac Risk Factors-2
The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to determine whether antidepressant augmentation with two grams of EPA omega-3 per day is superior to antidepressant therapy alone for major depression in patients with coronary heart disease (CHD).
Read the detailed description
Depression increases the risk for cardiac morbidity and mortality 2-4 fold in patients with coronary heart disease (CHD). Recent clinical trials have tested standard treatments for comorbid depression in patients with CHD, and some have evaluated their effects on cardiac morbidity and mortality. Most of these trials have shown that standard treatments have only modest effects on depression and have produced relatively small differences between the intervention and control condition. Consequently, they have been unable to determine whether effective treatment of depression can improve cardiac outcomes. Low dietary intake and low plasma phospholipid or erythrocyte levels of two omega-3 fatty acids(FAs), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are associated with depression and other cardiac risk markers. There is growing evidence from small psychiatric trials that the efficacy of standard antidepressants can be improved by coadministration of an omega-3 FA formulation containing at least 1 gram of EPA. The purpose of the proposed research is to determine whether antidepressant augmentation with this omega-3 formulation is superior to antidepressant therapy alone for major depression in patients with CHD. The proposed study is a randomized, placebo-controlled, double-blind clinical trial. Consenting patients with established coronary heart disease who meet the Diagnostic Statistical Manual (DSM)-5 criteria for a major depressive episode will undergo a baseline evaluation and then be randomly assigned to receive either 50 mg/day of sertraline plus omega-3 FA or 50 mg/day of sertraline plus placebo for 10 weeks. At baseline and after 10 weeks, participants will complete assessments of depression, 24 hour ambulatory ECG monitoring to measure 24 hour heart rate and heart rate variability, and blood draws to measure procoagulant and proinflammatory markers and blood levels of EPA, DHA, other omega-3 FAs, and the omega-6 FAs. If sertraline plus this omega-3 formulation significantly reduces depression compared to sertraline plus placebo, and if it improves or at least does not worsen other cardiovascular risk markers, this study will provide a strong basis for proposing a multicenter clinical trial of sertraline augmented with omega-3 to determine whether treatment of depression can improve survival in patients with CHD and depression.
- Conditions
- Depression
- Being tested
- Omega-3 supplement, Placebo
- Keywords
- Antidepressive agents, Coronary disease, Depression, Depressive disorder, Fatty Acids, Omega-3
- Medical subject headings
- Depression, Coronary Disease, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 supplementDrug
Also called EPA Plus Minami Nutrition
Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks
PlaceboDrug
Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 supplement | Experimental | Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks Receives: Drug: Omega-3 supplement |
| Placebo | Placebo comparator | Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory-II (BDI-II)
The BDI-II is a 21-item self-report inventory of depression symptoms. The minimum and maximum values for the BDI-II are (0-63). For both instruments, the higher the scores, the greater the severity of depression.
Measured: Change from baseline to 10 weeks (post-treatment)
Secondary outcomes (1)
Hamilton Depression Rating Scale (HAM-D, 17)
The HAM-D, 17 is a 17-item, observer-rated measure of depression symptoms. The minimum and maximum values for the HAM-D, (0-52). For both instruments, the higher the scores, the greater the severity of depression.
Measured: Change from baseline to 10 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study start14 May 2014
- Primary completion13 Sep 2018
- Study completion13 Sep 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Robert M Carney, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021669
- Sponsor's protocol ID
- 201309002
- Other IDs
- R01HL117805
- Acronym
- Omega-3(2)
- Status last verified
- Aug 2019
- First submitted
- 19 Dec 2013
- Last updated
- 4 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Carney RM, Freedland KE, Rubin EH, Rich MW, Steinmeyer BC, Harris WS. A Randomized Placebo-Controlled Trial of Omega-3 and Sertraline in Depressed Patients With or at Risk for Coronary Heart Disease. J Clin Psychiatry. 2019 Jun 4;80(4):19m12742. doi: 10.4088/JCP.19m12742.
PubMed 31163106
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 for Depression and Other Cardiac Risk Factors-2
- ClinicalTrials.gov ID
- NCT02021669
- Acronym / sponsor ID
- Omega-3(2) / 201309002
- Conditions
- Depression
- Keywords
- Antidepressive agents, Coronary disease, Depression, Depressive disorder, Fatty Acids, Omega-3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 May 2014 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Posted 6 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to determine whether antidepressant augmentation with two grams of EPA omega-3 per day is superior to antidepressant therapy alone for major depression in patients with coronary heart disease (CHD).
Detailed description
Depression increases the risk for cardiac morbidity and mortality 2-4 fold in patients with coronary heart disease (CHD). Recent clinical trials have tested standard treatments for comorbid depression in patients with CHD, and some have evaluated their effects on cardiac morbidity and mortality. Most of these trials have shown that standard treatments have only modest effects on depression and have produced relatively small differences between the intervention and control condition. Consequently, they have been unable to determine whether effective treatment of depression can improve cardiac outcomes. Low dietary intake and low plasma phospholipid or erythrocyte levels of two omega-3 fatty acids(FAs), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are associated with depression and other cardiac risk markers. There is growing evidence from small psychiatric trials that the efficacy of standard antidepressants can be improved by coadministration of an omega-3 FA formulation containing at least 1 gram of EPA. The purpose of the proposed research is to determine whether antidepressant augmentation with this omega-3 formulation is superior to antidepressant therapy alone for major depression in patients with CHD. The proposed study is a randomized, placebo-controlled, double-blind clinical trial. Consenting patients with established coronary heart disease who meet the Diagnostic Statistical Manual (DSM)-5 criteria for a major depressive episode will undergo a baseline evaluation and then be randomly assigned to receive either 50 mg/day of sertraline plus omega-3 FA or 50 mg/day of sertraline plus placebo for 10 weeks. At baseline and after 10 weeks, participants will complete assessments of depression, 24 hour ambulatory ECG monitoring to measure 24 hour heart rate and heart rate variability, and blood draws to measure procoagulant and proinflammatory markers and blood levels of EPA, DHA, other omega-3 FAs, and the omega-6 FAs. If sertraline plus this omega-3 formulation significantly reduces depression compared to sertraline plus placebo, and if it improves or at least does not worsen other cardiovascular risk markers, this study will provide a strong basis for proposing a multicenter clinical trial of sertraline augmented with omega-3 to determine whether treatment of depression can improve survival in patients with CHD and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 supplement | Experimental | Drug: Omega-3 supplementTwo grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks |
| Placebo | Placebo comparator | Drug: PlaceboTwo grams of corn oil plus 50 mg of sertraline daily for 10 weeks. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented coronary heart disease
- Diagnosis of major depression based on structured interview
Key exclusion criteria (9 listed)
- Moderate to severe cognitive impairment
- Meets DSM-5 criteria for depressive disorder due to a general medical condition or medication
- Major Axis I psychiatric disorder other than unipolar depression or an anxiety disorder, a high risk of suicide, or current substance abuse other than tobacco;
- Not expected to survive one year or physically unable to tolerate the study protocol
- Known sensitivity to sertraline or omega-3, or an allergy to fish oil or shellfish
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 supplementAlso: EPA Plus Minami NutritionTwo grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks | Drug | Omega-3 supplement |
| PlaceboTwo grams of corn oil plus 50 mg of sertraline daily for 10 weeks. | Drug | Placebo |
Primary outcome
Beck Depression Inventory-II (BDI-II)
Time frame: Change from baseline to 10 weeks (post-treatment)
The BDI-II is a 21-item self-report inventory of depression symptoms. The minimum and maximum values for the BDI-II are (0-63). For both instruments, the higher the scores, the greater the severity of depression.
1 secondary outcome
Hamilton Depression Rating Scale (HAM-D, 17)
Time frame: Change from baseline to 10 weeks (post-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31163106Carney RM, Freedland KE, Rubin EH, Rich MW, Steinmeyer BC, Harris WS. A Randomized Placebo-Controlled Trial of Omega-3 and Sertraline in Depressed Patients With or at Risk for Coronary Heart Disease. J Clin Psychiatry. 2019 Jun 4;80(4):19m12742. doi: 10.4088/JCP.19m12742.
- Individual participant dataSharing planned: No
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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.
Robert M Carney, PhD principal investigator
Washington University School of Medicine
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 supplement in people with Depression, run by Washington University School of Medicine 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 2 inclusion and 9 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 4 Sep 2019. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2019). 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?
Beck Depression Inventory-II (BDI-II) (time frame: Change from baseline to 10 weeks (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 NCT02021669, which also lists 1 linked publication.
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 4 Sep 2019.