E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language | |
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 | Understand the underlying mechanisms of the relationship between patient and physician. | |
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | Healthy, male subjects aged 18 to 35 years Subjects must be in good general health Refrain from alcohol/smoking/caffeine/drugs 24 hrs before the experiment Refrained from food/drinks (except water) and intensive exercise two hours before the administration of oxytocin Previous experience with healthcare system, in order to ensure that the subject is able to put himself in the role of a patient Subjects must be able to communicate well with the investigator in Dutch, to understand and comply with the requirements of the study, and understand and sign the written informed consent | |
E.4 | Principal exclusion criteria | Known hypersensitivity to oxytocin or to any of the excipients of oxytocin or placebo Participants who did not abstain from alcohol/smoking/caffeine/drugs 24 hrs before the experiment Participants who did not abstain from food/drinks (except water) and intensive exercise two hours before the administration of oxytocin Participants who did not meet the above specified inclusion criteria | |
E.5 End points |
E.5.1 | Primary end point(s) | Level of eye gaze from participant towards the eye area of the physician. Levels of participants’ trust in the physician. | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | Level of eye gaze: during the first video session and during the second video session. Levels of participants’ trust: after the first video session and after the second video session. | |
E.5.2 | Secondary end point(s) | Satisfaction with the physician: Measured with a visual analogue scale (VAS) ranging from 0 (not likely at all) to 100 (most likely) asking “I would recommend this doctor to a friend or family member.” Pupillometry: The measurement of pupil size and reactivity (dilation and restriction), measured with the Tobii screen eye tracker. Satisfaction with the doctors’ communication style: Measured with the Doctor Communication Style items (translated to Dutch with forward-backward translation) on two subscales: affiliativeness and dominance/activity. Items are answered on a 5-point Likert Scale from “strongly agree” to “strongly disagree”. Recall & Recognition (of information as explained during the medical communication video): Questionnaire which assesses participants’ level of free recall and recognition of information provided by the videotaped physician. The questionnaire will be designed based on the information provided in the video. | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | Satisfaction with the physician: after the first video session and after the second video session. Pupillometry: during the first video session and during the second video session. Satisfaction with the doctors’ communication style: after the first video session and after the second video session. Recall & Recognition:after the first video session and after the second video session. | |
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 | Understand the role of oxytocin with regard to the relationship between patient and physician. | |
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 | No |
E.8.1.6 | Cross over | Yes |
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 | |
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |