Acute effects of 40 mg cortisol on emotion and cognition.

Previous evidence suggests that large single doses of exogenous cortisol
(hydrocortisone) have acute effects on cognitive processing of emotional
stimuli. However, such effects of hydrocortisone on cognitive performance under
acute stress have never been tested even though this would be of considerable
fundamental and eventually possibly practical importance. This should be
investigated by assessing cognitive performance under stress and the influence
of hydrocortisone administration hereon.

To investigate acute effects of a single 40 mg dose hydrocortisone, compared
with placebo, on stress and various aspects of attention and other cognitive
processing of emotionally relevant stimuli in healthy anxious young females.
The main question is whether hydrocortisone counters the negative effects of
stress on executive cognitive performance. This may provide new information
about the role of cortisol in processes of emotion regulation under stress that
are important in affective psychopathology. This is a fundamental scientific
purpose. In particular, the proposed project will contribute to a better
understanding of the results obtained previously by the CME LUMC projects
reviewed P06.189 and P08.007. Please note that this is not a study of medicinal
properties, pharmacodynamics or *kinetics for a medicinal pharmacon. Rather,
this study investigates non-medicinal effects which are of fundamental interest
without direct medicinal relevance by a pharmacon that happens to be used for
unrelated medicinal purposes. As such this is not a *geneesmiddelenonderzoek*
as referred to in the WMO.

A double-blind, placebo-controlled between-subjects experiment.

Participants will receive either a placebo or 40 mg of hydrocortisone as
capsules for oral intake, in the afternoon after limited dietary restrictions
(no intake of nutrients 1.5 hour prior to drug/placebo administration).

Tax risks and benefits of participating subjects: The main burden on the
subjects is probably the time investment (about 3,5 hours) which is associated
with study participation. Participants perform a task with positive or negative
pictures (e.g. mutilated bodies or erotic pictures) that might be arousing,
that are commonly used for psychology experiments. A laboratory psychosocial
challenge will induce stress but that is not uncommon for students who
frequently undergo evaluation in the academic environment. Implementation of
some low-demand computerized cognitive tasks can be experienced as tiresome or
boring. A single administration of 40 mg of hydrocortisone does not lead to
subjectively noticeable effects on physical or mental functioning and is
harmless. Other than a relatively small monetary reward participation does not
offer direct personal benefit to the participant.
The aim of this study is closely related to an earlier study conducted in
Leiden University that have been previously approved by the Medical Ethics
Committee of the Leiden University Medical Center (CME IDs P06.189, P04.077,
P08.007, P11.195). All these studies employed the same study pharmacological
manipulation.