Angina, Unstable, Cardiovascular Diseases, Depression, Heart Diseases, Myocardial Infarction
Conditions
Brief summary
This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).
Detailed description
BACKGROUND: Depression is a risk factor for morbidity and mortality following an acute MI and unstable angina. Two recent studies (sertraline versus placebo and sertraline plus cognitive therapy versus usual care) reported only modest reductions in depression following an acute MI or unstable angina, and many treated patients remained depressed. Neither study reported better medical outcomes in the treated patients. Earlier studies found that even subclinical depression increases the risk of mortality in cardiac patients. Thus, more effective treatments are needed to eliminate depression and improve medical outcomes in patients following an acute MI or unstable angina. Omega-3 FAs have been shown to augment the efficacy of antidepressants for major depression and to improve several cardiac risk factors. However, these findings have been shown in separate lines of research. No previous study has investigated whether omega-3 FAs can simultaneously improve depression and reduce cardiovascular risk factors in post-MI patients. DESIGN NARRATIVE: One hundred fifty patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a current major depressive episode and who score 15 or higher on the Beck Depression Inventory II with a history of acute MI, unstable angina, or other cardiac event will be enrolled in a randomized, double-blind, placebo-controlled trial of omega-3 augmentation of sertraline. The participants will be randomly assigned to receive either sertraline plus omega-3 or sertraline plus placebo for 10 weeks. At baseline and again after ten weeks, the subjects will complete the following: 1) assessments of depression and psychosocial functioning; 2) 24-hour electrocardiogram monitoring for heart rate variability analysis; and 3) blood draws to measure procoagulant and proinflammatory markers, and plasma levels of sertraline and omega-3. If this study shows that omega-3 reduces depression and improves cardiovascular disease markers, there will be a basis for proposing a larger clinical trial to determine whether it can also improve survival after hospitalization for acute MI or unstable angina.
Interventions
DRUGSertraline/omega-3
Sertraline (50 mgs) plus omega-3 (2 grams)
DRUGSertraline/Corn Oil
Sertraline (50 mgs) plus corn oil (2 grams) (placebo)
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets the DSM-IV criteria for a current major depressive episode * Score of 15 or higher on the Beck Depression Inventory II * History of acute myocardial infarction, unstable angina, or documented coronary disease
Exclusion criteria
* Physician or patient refusal * Lives far away from study site * Current alcohol or drug abuse * Psychosis, dementia, or bipolar disorder * Already taking Omega-3 * Medically ill or disabled such that patient is unable to participate * Comorbid illness likely to be fatal within 1 year of study entry * Seizure disorder or takes anticonvulsants * Pregnant or breast feeding * Liver or kidney disease * Severe hypertriglyceridemia (greater than 400 mg/dL) * Bleeding or clotting disorder * Type 2 diabetes with a hemoglobin A1c (HbA1c) level greater than 10 * Taking lithium or monoamine oxidase inhibitor (MAO-I)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory-II | Measured at Baseline and 10 weeks | Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sertraline Plus Omega-3 Supplement Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday. | 62 |
| Sertraline/Corn Oil Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday. | 60 |
| Total | 122 |
Baseline characteristics
| Characteristic | Sertraline Plus Omega-3 Supplement | Sertraline/Corn Oil | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 48 Participants | 98 Participants |
| Age Continuous | 58.1 years STANDARD_DEVIATION 9.4 | 58.6 years STANDARD_DEVIATION 8.5 | 58.4 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 62 participants | 60 participants | 122 participants |
| Sex: Female, Male Female | 22 Participants | 19 Participants | 41 Participants |
| Sex: Female, Male Male | 40 Participants | 41 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 62 | 0 / 60 |
| serious Total, serious adverse events | 0 / 62 | 0 / 60 |
Outcome results
Primary
Beck Depression Inventory-II
Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.
Time frame: Measured at Baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline Plus Omega-3 Supplement | Beck Depression Inventory-II | 16.1 units on a scale | Standard Deviation 10.2 |
| Sertraline/Corn Oil | Beck Depression Inventory-II | 14.8 units on a scale | Standard Deviation 9.7 |