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Effect of Escitalopram in Patients With Heart Failure and Depression
Study Questions:
What is the effect of escitalopram on mortality, morbidity, and mood in patients with chronic systolic heart failure and depression?
Methods:
The MOOD-HF (Effects of Selective Serotonin Re-Uptake Inhibition on Morbidity, Mortality, and Mood in Depressed Heart Failure Patients) study was a double-blind, placebo-controlled randomized clinical trial conducted at 16 tertiary medical centers in Germany. Between March 2009 and February 2014, patients at outpatient clinics with New York Heart Association class II-IV heart failure and reduced left ventricular ejection fraction (<45%) were screened for depression using the nine-item Patient Health Questionnaire. Patients with suspected depression were then invited to undergo a Structured Clinical Interview based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) to establish the diagnosis. Patients were randomized 1:1 to receive escitalopram (10-20 mg) or matching placebo in addition to optimal heart failure therapy. Study duration was 24 months. The composite primary outcome was time to all-cause death or hospitalization. Prespecified secondary outcomes included safety and depression severity at 12 weeks of treatment (including the titration period), which were determined using the 10-item Montgomery-Åsberg Depression Rating Scale (total possible score, 0-60; higher scores indicate more severe depression).
Results:
A total of 372 patients (mean age, 62 years; 24% female) were randomized and had taken at least one dose of study medication when the Data and Safety Monitoring Committee recommended the trial be stopped early. During a median participation time of 18.4 months (n = 185) for the escitalopram group and 18.7 months (n = 187) for the placebo group, the primary outcome of death or hospitalization occurred in 116 (63%) patients and 119 (64%) patients, respectively (hazard ratio, 0.99; 95% confidence interval [CI], 0.76-1.27; p = 0.92). The mean Montgomery Åsberg Depression Rating Scale sum score changed from 20.2 at baseline to 11.2 at 12 weeks in the escitalopram group, and from 21.4 to 12.5 in the placebo group (between-group difference, −0.9 [95% CI,−2.6 to 0.7]; p = 0.26). Safety parameters were comparable between groups.
Conclusions:
The authors concluded that in patients with chronic heart failure with reduced ejection fraction and depression, 18 months of treatment with escitalopram compared with placebo did not significantly reduce all-cause mortality or hospitalization.
Perspective:
This study reports that in patients with chronic heart failure with reduced ejection fraction and depression, 18 months of treatment with escitalopram did not significantly reduce all-cause mortality or hospitalization, and there was no significant improvement in depression. These findings do not support the use of escitalopram in patients with chronic systolic heart failure and depression. These results are similar to those of the Sertraline Antidepressant Heart Attack Randomized Trial and the Enhancing Recovery in Coronary Heart Disease study, both of which enrolled patients with coronary disease and depression and found no beneficial effects with 6 months of antidepressant treatment.
Keywords: Ambulatory Care Facilities, Antidepressive Agents, Citalopram, Depression, Depressive Disorder, Major, Geriatrics, Heart Failure, Heart Failure, Systolic, Hospitalization, Myocardial Infarction, Secondary Prevention, Serotonin Uptake Inhibitors, Stroke Volume
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