Clinical Trial Results:
Effects of selective serotonin re-uptake inhibition on morbidity, mortality and mood in Depressed Heart Failure patients
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Summary
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EudraCT number |
2007-006609-25 |
Trial protocol |
DE |
Global end of trial date |
02 Sep 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Jun 2021
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First version publication date |
04 Jun 2021
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Other versions |
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Summary report(s) |
MOOD-HF_Synopsis |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MOOD-HF
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Additional study identifiers
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ISRCTN number |
ISRCTN33128015 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Universität Würzburg
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Sponsor organisation address |
Sanderring 2, Würzburg, Germany, 97078
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Public contact |
Deutsches Zentrum für Herzinsuffizi, University Hospital Würzburg, ++49 93120146361, Angermann_C@ukw.de
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Scientific contact |
Deutsches Zentrum für Herzinsuffizi, University Hospital Würzburg, ++49 93120146361, Angermann_C@ukw.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Sep 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Sep 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Sep 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to investigate the effects of treatment with the SSRI escitalopram compared to placebo on morbidity and mortality in CHF patients with a current episode of major depression
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Protection of trial subjects |
Patients were closely monitored with regard to safety during the course of the study, with several secondary endpoints as indicators for safety based on the underlying disease.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Mar 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 376
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Worldwide total number of subjects |
376
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EEA total number of subjects |
376
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
217
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From 65 to 84 years |
157
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85 years and over |
2
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Recruitment
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Recruitment details |
Between March, 2009, and September, 2014, 372 patients from 16 German trial sites were enrolled to the MOOD-HF trial. | |||||||||
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Pre-assignment
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Screening details |
Patients were eligible for the trial, if they were >= 18 years of age, had chronic systolic heart failure of any etiology (current NYHA class II-IV and >= one measurement of LVEF <45% within the preceding three months) and had a diagnosis of current major DEP based on the Structured Clinical Interview for DSM-IV (SCID). | |||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Investigator, Subject | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Escitalopram | |||||||||
Arm description |
Cardiological care + escitalopram 10-20 mg/day p.o. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Escitalopram
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Investigational medicinal product code |
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Other name |
Cipralex®
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Patients started with a dose of 5 mg once daily and were uptitrated after 3 weeks to 10 mg once daily. After further three weeks patients up to 65 years old were uptitrated to 20 mg/day. Slower up-titration was permitted for tolerability reasons. Twelve weeks after study start the final dosage of study drug had to be reached.
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Arm title
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Placebo | |||||||||
Arm description |
Cardiological care + placebo 10-20 mg/day p.o. | |||||||||
Arm type |
Placebo control | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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End points reporting groups
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Reporting group title |
Escitalopram
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Reporting group description |
Cardiological care + escitalopram 10-20 mg/day p.o. | ||
Reporting group title |
Placebo
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Reporting group description |
Cardiological care + placebo 10-20 mg/day p.o. | ||
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End point title |
Effect of selective serotonin re-uptake inhibition on morbidity and mortality in depressed patients with CHF [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The primary endpoint is measured by the time to a first clinical event, either death or unplanned hospitalisation, whichever occurs first.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: For analysis results please see attached pdf or JAMA. 2016 Jun 28;315(24):2683-93. doi: 10.1001/jama.2016.7635 |
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| Notes [2] - One patient discontinued trial participation before starting IMP [3] - Three patients discontinued trial participation before starting IMP |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse Event reporting was mandatory from screening until the last visit of a patient.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
17.0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: For a description and summary of non-serious adverse events please see attached pdf |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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09 Dec 2008 |
- exclusion criteria: 1. moderate and severe dementia (MMSE <18) (moderate) / 2. Thyreotoxicosis (new exclusion criteria)
- study medication: start dosis of 10 mg/d is possible according to the recommendation of the consulting psychiatrist
- change of 2 stratification features (PHQ-sum score and hospitalization within the past 4 weeks at the time of SCID
- a new secondary endpoint (effect of optimized cardiological care)
- update of the assessment of patients
- change in documentation and reporting of SAE
- new trial site
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24 Sep 2009 |
Addition of two new trial sites (university of Rostock and university of Leipzig) and closing of the trial site Charité Berlin |
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22 Jun 2010 |
Three new trial sites (Universitäres Herzzentrum Hamburg, Medizinische Hochschule Hannover and Universität Magdeburg). |
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23 Feb 2011 |
New investigator (PZ Würzburg) |
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23 Feb 2011 |
Change in contact data at the trial site in Würzburg incl. resulting change in IMPD-label |
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10 May 2011 |
- Transfer of patients for SCID stariong at PHQ-9-sum of 9 (up to amendment: 12)
- introduction of a new scientific side project (Fe-MOOD)
- three new tral sites
- deregistration of two trial sites
- registration of new investigators at already registered trial sites
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12 Sep 2011 |
- change in an exclusion criterion
- registration of a new trial site (Uniklinikum Regensburg)
- registration of new investigators
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28 Oct 2011 |
- addition of two new exclusion criteria
- reduktion of maximum daily dose to 10 mg in patients aged >=65 years
- registration and deregistration of trial sites
- PI-change in Hamburg
- registration and deregistration of investigators
- Recalculation of subject number
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23 Oct 2012 |
- PI-change in Hannover and Lübeck
- deregistration of Stuttgart
- registration of new investigators
- change in contact data of the trial bimetrician
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24 May 2013 |
- PI-change in Lübeck and Marburg
- registration of deputy investigators at already registered trial sites (Bad Nauheim, Bonn, Homburg/Saar, Leipzig), die noch nicht als Prüfer bewertet wurden
- deregistration of trial sites (Hannover, Mannheim, München and Regensburg)
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05 Mar 2014 |
- trial duration and definition of the end of trial
- reduction of the package size of the study medication starting with the current batch.e
- Update of data related to the trial team (contacts, members of the endpoint committee)
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
