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Het effect van Spironolactone op geheugenprestatie onder stressvolle omstandigheden.


- candidate number5431
- NTR NumberNTR1701
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mrt-2009
- Secondary IDsNL26301.068.08 CCMO en MEC/azM
- Public TitleHet effect van Spironolactone op geheugenprestatie onder stressvolle omstandigheden.
- Scientific TitleThe effect of Spironolactone on memory performance under stressful circumstances.
- ACRONYMN/A
- hypothesisWhile the role of the Mineralocorticoid Receptor (MR) in learning and memory under stress has recently been investigated in animal work, little is know about the exact role of the MR in modulating memory performance under stress in humans. Therefore, the current study addresses the effects of MR blockade on memory performance under stressful and non-stressful conditions, to address the role of the membrane and nuclear MR respectively. More specifically: What effects does the MR antagonist Spironolactone have on memory performance 24 hours after learning a word list preceded by a Trier Social Stress Test (TSST) or a non-stressful control task?
- Healt Condition(s) or Problem(s) studiedHealthy subjects
- Inclusion criteriaHealthy male volunteers aged 18-35y will be recruited for this study. They will undergo a short medical examination before participating.
- Exclusion criteria1. Suffering from cardiovascular diseases, severe physical illness, hypertension, current or lifetime psychopathology or endocrine disorders;
2. Being on medication known to affect HPA-axis functioning;
3. Use of Acetyl Salicylic Acid;
4. Renal insufficiency;
5. Hyperkalemia .
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2009
- planned closingdate1-dec-2009
- Target number of participants64
- InterventionsThe current study will use a double-blind, placebo controlled design. One group will receive Spironolactone (400mg in a single dose on one day only) and engage in the Trier Social Stress Test (TSST; Kirschbaum et al. 1993) before undergoing memory tests; one group will receive the same dose of Spironolactone and engage in a non-stressful control task; another group will receive a placebo and be exposed to the TSST; while the fourth group will receive a placebo and engage in a non-stressful control task (n=16 per group).
- Primary outcomeThe main study parameter is the memory performance on the surprise recall test of the word list, learned 24 hours before, in the four experimental groups (stress vs non-stress X Spironolactone vs placebo). The memory performance on the recall test depends on the amount of remembered words from four different categories: stress related non-arousing words, stress-related arousing words, stress-unrelated non-arousing words and stress-unrelated arousing words. The validity of this procedure as well as these specific word lists has been shown elsewhere (Smeets et al., 2007, in press). For example, Smeets et al. (in press) recently showed that when learning coincided with stress exposure, immediate and delayed recall of stressor-related high arousing words is enhanced relative to stressor-unrelated words, at the expense of delayed recall of stressor-related low arousing words. Moreover, this enhanced learning and memory effect of post-stress learning correlated with stress-induced cortisol elevations in conjunction with high sympathetic activity as measured by salivary alpha-amylase, but not with changes in either of the hormones alone.
- Secondary outcomeSecondary study parameters are the salivary cortisol and alpha-amylase levels at several time points during the experiment and heart rate and blood pressure levels throughout the experiment. Furthermore we would like to check the effects of Spironolactone on selective attention and working memory.
- TimepointsLearning and memory will be assessed with 3 immediate recall tests and one 24hr delayed recall test. Blood pressure, cortisol, and alpha-amylase will be sampled at 5 time points (4 times during the first memory encoding and immediate recall session; once during the 24hr delayed recall session).
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. T. Smeets
- CONTACT for SCIENTIFIC QUERIESDrs. T. Smeets
- Sponsor/Initiator University Maastricht (UM), Faculty of Psychology and Neuroscience
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM), Faculty of Psychology and Neuroscience
- PublicationsN/A
- Brief summaryWhile the role of the Mineralocorticoid Receptor (MR) in learning and memory under stress has recently been investigated in animal work, little is know about the exact role of the MR in modulating memory performance under stress in humans. Therefore, the current study addresses the effects of MR blockade by Spironolactone on memory performance under stressful and non-stressful conditions, to address the role of the membrane and nuclear MR respectively. The primary objective of this study is to investigate the role of the MR in memory performance under stressful and non-stressful conditions in humans. More specifically the following question will be answered: What effects does the MR antagonist Spironolactone have on memory performance 24 hours after learning a word list preceded by a Trier Social Stress Test (TSST) or a non-stressful control task? The current study will use a double-blind, placebo controlled design; a total of 64 healthy young (aged 18-35) male undergraduate students will be recruited. One group will receive Spironolactone (400mg single administration on one day only) and engage in the TSST before undergoing memory tests; one group will receive the same dose of Spironolactone and engage in a non-stressful control task; another group will receive a placebo and be exposed to the TSST; while the fourth group will receive a placebo and engage in a non-stressful control task (n=16 per group). Learning curves at memory encoding phase (i.e., 3 immediate free recall tests) and 24hr delayed free recall performance will be assessed.
- Main changes (audit trail)
- RECORD9-mrt-2009 - 14-jan-2010


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