E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
There are no medical conditions or disease under investigation. |
Er worden geen ziekten onderzocht |
|
E.1.1.1 | Medical condition in easily understood language |
not applicable |
niet van toepassing |
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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 |
Main objective is to examine effects of oxytocin on stress reactivity |
Doel is om effecten van oxytocine op stress reactiviteit te onderzoeken |
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E.2.2 | Secondary objectives of the trial |
Combined effects of oxytocin and social support on stress reactivity: to examine whether oxytocin enhances the beneficial effects of social support |
Gecombineerde effecten van oxytocine en social support: we gaan onderzoeken of oxytocine de positieve effecten van sociale steun verhoogt |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Combined effects of oxytocin and social support on reactivity to social stress and physical stress |
Gecombineerde effecten van oxytocine en sociale steun op reactiviteit tijdens sociale stress en fysieke stress |
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E.3 | Principal inclusion criteria |
18-30 years, women |
18-30 jaar, vrouwen |
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E.4 | Principal exclusion criteria |
pregnancy, breastfeeding, women with children, cardiovascular disease |
pregnancy, breastfeeding, women with children, cardiovascular disease |
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E.5 End points |
E.5.1 | Primary end point(s) |
stress reactivity: heart rate reactivity, salivary cortisol levels and subjective stress measured with questionnaires.
Stress reactivity of 4 groups of participants will be measured:
1) participants who receive intranasal oxytocin and receive social support from a friend during stress
2) participants who receive intranasal oxytocin and who do not receive social support from a friend during stress
3) participants who receive a placebo and receive social support from a friend during stress
4) participants who receive a placebooxytocin and who do not receive social support from a friend during stress
Expected end point: reduced stress reactivity in the oxytocin condition, with most pronounced oxytocin effects when there is social support from a friend |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
we will examine effects of intranasal oxytocin on stress reactivity during a social stress test (a virtual version of the Trier Social Stress Test) and a physical stress test (the Cold Pressor Test). Stress levels will be measured before oxytocin administration, immediately after administration, during the stress tests and afterwards. Saliva will be collected to measure cortisol, heart rate will be measured with the VU-AMS device, and subjective stress will be measured with questionnaires. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
we will examine effects of oxytocin on stress reactivity during a social stress test and a physical stress test. Stress levels will be measured before oxytocin administration, immediately after administration, during the stress tests and afterwards. |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
positive effects of oxytocin on stress reactivity |
positive effects of oxytocin on stress reactivity |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |