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van CCT (UK)

van CCT (UK)

Conditioning cortisol

- candidate number18164
- NTR NumberNTR4651
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jun-2014
- Secondary IDsNL47105.058.14 14.020 CME LUMC
- Public TitleConditioning cortisol
- Scientific TitleConditioning cortisol and its psychophysiological effects
- hypothesisConditioning with hydrocortisone will result in altered endogenous cortisol during rest in the evocation phase.
- Healt Condition(s) or Problem(s) studiedCortisol, Healthy volunteers
- Inclusion criteriahealthy, female, premenopausal, 18-30 years of age
- Exclusion criteriaSomatic and/or psychiatric diseases, symptoms of infection, use of medication (including oral contraceptives), recent stressful life events
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-jun-2014
- planned closingdate31-dec-2018
- Target number of participants48
- InterventionsIn the experimental group, cortisol is elevated exogenously on three consecutive days by administration of 100 mg hydrocortisone. In the control group, a placebo is administered at the same time points.
- Primary outcomeThe main study parameter is the AUCg of endogenous cortisol during rest in the evocation phase.
- Secondary outcomeSecondary study parameters are the AUCg of endogenous cortisol during exposure to a short-term psychosocial stress task. Alpha-amylase and self-reported well-being during rest and during exposure to a short-term psychosocial stress task in the evocation phase are additional secondary parameters.
- TimepointsDuring the sessions, cortisol, alpha-amylase and self-reported well-being are measured at several time points
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryBackground:
Preliminary evidence suggests that it might be possible to condition endogenous cortisol, with subsequent psychophysiological effects. In a pilot study with ten participants, promising indications were found for conditioned effects on endogenous cortisol levels and other psychophysiological outcomes. When more systematic research in a larger sample would support these findings, the ability to condition cortisol could offer new therapeutic possibilities.
The aim of this study is to investigate the effects of conditioning with hydrocortisone on endogenous cortisol. Effects of conditioning on endogenous cortisol in response to a short-term psychosocial stress task and other psychophysiological outcomes will also be explored.

Study design:
In line with previous conditioning studies as well as the previous pilot study in ten participants with an analogous design conducted by the research group, a randomized placebo-controlled conditioning paradigm consisting of 2 phases will be applied. In the acquisition phase, consisting of 3 sessions on 3 consecutive days, an unconditioned stimulus (experimental condition: hydrocortisone pill; control condition: placebo pill) is paired with a conditioned stimulus (novel tasting beverage). In the evocation phase, also consisting of 3 sessions on 3 consecutive days a week after the acquisition phase, all participants will be administered a placebo pill paired with the same beverage as in the acquisition phase. Cortisol, alpha-amylase, and self-reported well-being will be measured at several time points during the 6 acquisition and evocation sessions. During each session, participants will also be asked to perform some cognitive tasks and during the last session participants will be exposed to a short-term psychosocial stress task.
- Main changes (audit trail)
- RECORD18-jun-2014 - 10-apr-2018

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