Het effect van Spironolactone op geheugenprestatie onder stressvolle omstandigheden.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR1701
• Date of registration: 09/03/2009
• Primary sponsor: University Maastricht (UM), Faculty of Psychology and Neuroscience
• Public title: Het effect van Spironolactone op geheugenprestatie onder stressvolle omstandigheden.
• Scientific title: The effect of Spironolactone on memory performance under stressful circumstances. - N/A
• Date of first enrolment: 1/4/2009
• Target sample size: 64
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1701
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: T. Smeets

• Name: T. Smeets

Key inclusion & exclusion criteria

Inclusion criteria: Healthy male volunteers aged 18-35y will be recruited for this study. They will undergo a short medical examination before participating.
Exclusion criteria: 1. 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 .


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Healthy subjects

Intervention(s)

The 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 Outcome(s)

The 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 Outcome(s)

Secondary 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.

Secondary ID(s)

NL26301.068.08

Source(s) of Monetary Support

University Maastricht (UM), Faculty of Psychology and Neuroscience