E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
None (healthy participants). |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Psychological processes [F02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate whether single administration of hydrocortisone will prevent the negative effects of stress on cognition and automatic attentional threat processing; participants in the hydrocortisone group will show reduced objectively assessed interference by negative information and self-reported cognitive interference during performance, and better cognitive performance. |
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E.2.2 | Secondary objectives of the trial |
It is expected that frontal EEG theta/beta ratio will predict attentional function in the placebo group and moderate the effects of hydrocortisone on cognition; the group differences for placebo versus cortisol on cognitive performance and automatic attentional threat processing will be most pronounced among participants with higher baseline TBR (low cognitive control).
Moreover, it is expected that effects of cortisol and moderation thereof by theta/beta ratio will also depend on trait anxiety and self-reported trait attentional control (e.g, Putman et al 2007; Schoorl et al., 2014).
Finally we expect to replicate the negative relationship between frontal EEG theta/beta ratio and self-reported attentional control (see, Putman et al., 2010, 2014; Angelidis et al., 2016).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) relatively high scores on a self-reported trait cognitive test anxiety scale and trait social anxiety. We will aim at testing participants who score above the population’s median score for this scale, as this should increase the baseline effects of stress on cognition and therefor optimize the study’s design for observing effects of cortisol. For practical reasons and reasons of external validity, we set no strict cut off score for inclusion, but rather pragmatically aim to test the higher scoring of respondents.
2) females
3) Age 18-25 years.
4) Right-handed.
5) Normal, or corrected to normal vision.
6) stable (> 3 months) use of monophase orall anti-conceptives (between the 3rd and the 20th day of their menstrual cycle.
7) 18 < BMI < 26
8) fluent in Dutch
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E.4 | Principal exclusion criteria |
1) Treatment for psychiatric, endocrine or neurological (CNS) medical problems in the past or present.
2) Use of any medication other than occasional use of OTC medications
3) Use of corticosteroid medication (oral, nasal, injected) in the 6 months prior to enrollment or dermal corticosteroid medication in the week prior to enrollment.
4) Regular smoking (more than 10 cigarettes per week) or any in the 12 hours prior to testing.
5) Use of more than three alcoholic units per day.
6) Frequent or recent use of cannabis (on average once a week or more frequent in the three months prior to enrollment or single use or more in the week prior to enrollment).
7) Any use of recreational drugs other than cannabis in the three months prior to enrollment.
8) Use of more than 3 units of alcohol in the last 24 hours, use of alcohol during the last 12 hours, or consumption of any other recreational drug in the last 24 hours prior to testing.
9) Intensive physical cardiovascular sports training for more than 1 hour, at least 5 days a week.
10) pregnancy
11) lactation
12) Raynaud syndrome |
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E.5 End points |
E.5.1 | Primary end point(s) |
objective and subjective emotional interference, executive cognitive performance, |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 hour after intervention |
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E.5.2 | Secondary end point(s) |
EEG theta/beta ratio, trait cognitive test anxiety, trait attentional control |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 hour before intervention |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |