Clinical Trial Results:
Effects of mineralocorticoid receptor stimulation on cognitive bias and social cognition in patients with major depression and healthy controls: what’s the role of NMDA receptors?
Summary
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EudraCT number |
2014-005239-15 |
Trial protocol |
DE |
Global end of trial date |
11 Feb 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
14 May 2021
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First version publication date |
14 May 2021
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Other versions |
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Summary report(s) |
MISO_summary |
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 |
MISO
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03062150 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Charité - Universitätsmedizin Berlin
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Sponsor organisation address |
Hindenburgdamm 30, Berlin, Germany,
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Public contact |
Christian Otte, Klinik für Psychiatrie und Psychoth, Charité - Universitätsmedizin Berlin, +49 30450 517531, christian.otte@charite.de
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Scientific contact |
Christian Otte, Klinik für Psychiatrie und Psychoth, Charité - Universitätsmedizin Berlin, +49 30450 517531, christian.otte@charite.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 |
11 Feb 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Feb 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Feb 2019
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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 the study is to investigate the effects of fludrocortisone versus placebo on the attention bias in a pooled group of depressive patients and healthy control subjects (measured by the „Attentional bias index“ in the emotional dot probe paradigm)
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Protection of trial subjects |
Safety: Blood pressure, heart rate, measures of subjective well-being (Visual Analogue Mood Scales, VAMS), adverse events (AE), serious adverse events (SAE), serious adverse reactions (SAR)
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Sep 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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: 232
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Worldwide total number of subjects |
232
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EEA total number of subjects |
232
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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) |
230
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
Pre-assignment
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Screening details |
Diagnosis and main criteria for inclusion: - Age 18-65 years - Depressed male and female patients according to DSM-V & minimum of 17-items Hamilton Depression Score of 18 - healthy controls | |||||||||||||||
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 |
Subject, Investigator, Monitor | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Fludrocortisone + Placebo | |||||||||||||||
Arm description |
Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Fludrocortisone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.
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Arm title
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Placebo + D-Cycloserine | |||||||||||||||
Arm description |
Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH. D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
D-Cycloserine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.
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Arm title
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Fludrocortisone+D-Cycloserine | |||||||||||||||
Arm description |
Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Fludrocortisone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.
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Investigational medicinal product name |
D-Cycloserine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd
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Arm title
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Placebo + Placebo | |||||||||||||||
Arm description |
Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH. | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.
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Baseline characteristics reporting groups
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Reporting group title |
Fludrocortisone + Placebo
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Reporting group description |
Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo + D-Cycloserine
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Reporting group description |
Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH. D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fludrocortisone+D-Cycloserine
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Reporting group description |
Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo + Placebo
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Reporting group description |
Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Fludrocortisone + Placebo
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Reporting group description |
Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH. | ||
Reporting group title |
Placebo + D-Cycloserine
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Reporting group description |
Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH. D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd | ||
Reporting group title |
Fludrocortisone+D-Cycloserine
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Reporting group description |
Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd | ||
Reporting group title |
Placebo + Placebo
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Reporting group description |
Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH. |
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End point title |
Emotional dot probe | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
1 hour
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Statistical analysis title |
Emotional Dot Probe | |||||||||||||||
Comparison groups |
Fludrocortisone + Placebo v Placebo + D-Cycloserine v Fludrocortisone+D-Cycloserine v Placebo + Placebo
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Number of subjects included in analysis |
232
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
< 0.05 | |||||||||||||||
Method |
ANOVA | |||||||||||||||
Parameter type |
Mean difference (final values) | |||||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Day of assessment
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
own system | ||
Dictionary version |
1
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Frequency threshold for reporting non-serious adverse events: 0% | |||
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: No AE, SEA SAR reported. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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 |