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Effect of Escitalopram on All-Cause Mortality and Hospitalization in Patients With Heart Failure and Depression: The MOOD-HF Randomized Clinical Trial

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Effect of Escitalopram on All-Cause Mortality and Hospitalization in Patients With Heart Failure and Depression: The MOOD-HF Randomized Clinical Trial. / Angermann, Christiane E; Gelbrich, Götz; Störk, Stefan; Gunold, Hilka; Edelmann, Frank; Wachter, Rolf; Schunkert, Heribert; Graf, Tobias; Kindermann, Ingrid; Haass, Markus; Blankenberg, Stephan; Pankuweit, Sabine; Prettin, Christiane; Gottwik, Martin; Böhm, Michael; Faller, Hermann; Deckert, Jürgen; Ertl, Georg; MOOD-HF Study Investigators and Committee Members.

In: JAMA-J AM MED ASSOC, Vol. 315, No. 24, 28.06.2016, p. 2683-2693.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Angermann, CE, Gelbrich, G, Störk, S, Gunold, H, Edelmann, F, Wachter, R, Schunkert, H, Graf, T, Kindermann, I, Haass, M, Blankenberg, S, Pankuweit, S, Prettin, C, Gottwik, M, Böhm, M, Faller, H, Deckert, J, Ertl, G & MOOD-HF Study Investigators and Committee Members 2016, 'Effect of Escitalopram on All-Cause Mortality and Hospitalization in Patients With Heart Failure and Depression: The MOOD-HF Randomized Clinical Trial', JAMA-J AM MED ASSOC, vol. 315, no. 24, pp. 2683-2693. https://doi.org/10.1001/jama.2016.7635

APA

Angermann, C. E., Gelbrich, G., Störk, S., Gunold, H., Edelmann, F., Wachter, R., Schunkert, H., Graf, T., Kindermann, I., Haass, M., Blankenberg, S., Pankuweit, S., Prettin, C., Gottwik, M., Böhm, M., Faller, H., Deckert, J., Ertl, G., & MOOD-HF Study Investigators and Committee Members (2016). Effect of Escitalopram on All-Cause Mortality and Hospitalization in Patients With Heart Failure and Depression: The MOOD-HF Randomized Clinical Trial. JAMA-J AM MED ASSOC, 315(24), 2683-2693. https://doi.org/10.1001/jama.2016.7635

Vancouver

Angermann CE, Gelbrich G, Störk S, Gunold H, Edelmann F, Wachter R et al. Effect of Escitalopram on All-Cause Mortality and Hospitalization in Patients With Heart Failure and Depression: The MOOD-HF Randomized Clinical Trial. JAMA-J AM MED ASSOC. 2016 Jun 28;315(24):2683-2693. https://doi.org/10.1001/jama.2016.7635

Bibtex

@article{83b9cee58d0347aebc4676846c8ed189,
title = "Effect of Escitalopram on All-Cause Mortality and Hospitalization in Patients With Heart Failure and Depression: The MOOD-HF Randomized Clinical Trial",
abstract = "IMPORTANCE: Depression is frequent in patients with heart failure and is associated with adverse clinical outcomes. Long-term efficacy and safety of selective serotonin reuptake inhibitors in these patients are unknown.OBJECTIVE: To determine whether 24 months of treatment with escitalopram improves mortality, morbidity, and mood in patients with chronic systolic heart failure and depression.DESIGN, SETTING, AND PARTICIPANTS: The Effects of Selective Serotonin Re-Uptake Inhibition on Morbidity, Mortality, and Mood in Depressed Heart Failure Patients (MOOD-HF) 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 9-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.INTERVENTIONS: 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.MAIN OUTCOMES AND MEASURES: 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-{\AA}sberg Depression Rating Scale (total possible score, 0 to 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 1 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% CI, 0.76 to 1.27]; P = .92). The mean Montgomery-{\AA}sberg 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 = .26). Safety parameters were comparable between groups.CONCLUSIONS AND RELEVANCE: 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, 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.TRIAL REGISTRATION: isrctn.com Identifier: ISRCTN33128015.",
keywords = "Affect, Aged, Antidepressive Agents, Second-Generation, Chronic Disease, Citalopram, Depression, Drug Administration Schedule, Female, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Morbidity, Psychiatric Status Rating Scales, Stroke Volume, Treatment Outcome, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",
author = "Angermann, {Christiane E} and G{\"o}tz Gelbrich and Stefan St{\"o}rk and Hilka Gunold and Frank Edelmann and Rolf Wachter and Heribert Schunkert and Tobias Graf and Ingrid Kindermann and Markus Haass and Stephan Blankenberg and Sabine Pankuweit and Christiane Prettin and Martin Gottwik and Michael B{\"o}hm and Hermann Faller and J{\"u}rgen Deckert and Georg Ertl and {MOOD-HF Study Investigators and Committee Members} and Bernd L{\"o}we and Kai M{\"u}llerleile",
year = "2016",
month = jun,
day = "28",
doi = "10.1001/jama.2016.7635",
language = "English",
volume = "315",
pages = "2683--2693",
journal = "JAMA-J AM MED ASSOC",
issn = "0098-7484",
publisher = "American Medical Association",
number = "24",

}

RIS

TY - JOUR

T1 - Effect of Escitalopram on All-Cause Mortality and Hospitalization in Patients With Heart Failure and Depression: The MOOD-HF Randomized Clinical Trial

AU - Angermann, Christiane E

AU - Gelbrich, Götz

AU - Störk, Stefan

AU - Gunold, Hilka

AU - Edelmann, Frank

AU - Wachter, Rolf

AU - Schunkert, Heribert

AU - Graf, Tobias

AU - Kindermann, Ingrid

AU - Haass, Markus

AU - Blankenberg, Stephan

AU - Pankuweit, Sabine

AU - Prettin, Christiane

AU - Gottwik, Martin

AU - Böhm, Michael

AU - Faller, Hermann

AU - Deckert, Jürgen

AU - Ertl, Georg

AU - MOOD-HF Study Investigators and Committee Members

AU - Löwe, Bernd

AU - Müllerleile, Kai

PY - 2016/6/28

Y1 - 2016/6/28

N2 - IMPORTANCE: Depression is frequent in patients with heart failure and is associated with adverse clinical outcomes. Long-term efficacy and safety of selective serotonin reuptake inhibitors in these patients are unknown.OBJECTIVE: To determine whether 24 months of treatment with escitalopram improves mortality, morbidity, and mood in patients with chronic systolic heart failure and depression.DESIGN, SETTING, AND PARTICIPANTS: The Effects of Selective Serotonin Re-Uptake Inhibition on Morbidity, Mortality, and Mood in Depressed Heart Failure Patients (MOOD-HF) 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 9-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.INTERVENTIONS: 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.MAIN OUTCOMES AND MEASURES: 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 to 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 1 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% CI, 0.76 to 1.27]; P = .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 = .26). Safety parameters were comparable between groups.CONCLUSIONS AND RELEVANCE: 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, 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.TRIAL REGISTRATION: isrctn.com Identifier: ISRCTN33128015.

AB - IMPORTANCE: Depression is frequent in patients with heart failure and is associated with adverse clinical outcomes. Long-term efficacy and safety of selective serotonin reuptake inhibitors in these patients are unknown.OBJECTIVE: To determine whether 24 months of treatment with escitalopram improves mortality, morbidity, and mood in patients with chronic systolic heart failure and depression.DESIGN, SETTING, AND PARTICIPANTS: The Effects of Selective Serotonin Re-Uptake Inhibition on Morbidity, Mortality, and Mood in Depressed Heart Failure Patients (MOOD-HF) 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 9-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.INTERVENTIONS: 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.MAIN OUTCOMES AND MEASURES: 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 to 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 1 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% CI, 0.76 to 1.27]; P = .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 = .26). Safety parameters were comparable between groups.CONCLUSIONS AND RELEVANCE: 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, 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.TRIAL REGISTRATION: isrctn.com Identifier: ISRCTN33128015.

KW - Affect

KW - Aged

KW - Antidepressive Agents, Second-Generation

KW - Chronic Disease

KW - Citalopram

KW - Depression

KW - Drug Administration Schedule

KW - Female

KW - Heart Failure

KW - Hospitalization

KW - Humans

KW - Male

KW - Middle Aged

KW - Morbidity

KW - Psychiatric Status Rating Scales

KW - Stroke Volume

KW - Treatment Outcome

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1001/jama.2016.7635

DO - 10.1001/jama.2016.7635

M3 - SCORING: Journal article

C2 - 27367876

VL - 315

SP - 2683

EP - 2693

JO - JAMA-J AM MED ASSOC

JF - JAMA-J AM MED ASSOC

SN - 0098-7484

IS - 24

ER -