E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
There are no medical conditions or diseases under investigation, participants are healthy volunteers. |
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E.1.1.1 | Medical condition in easily understood language |
There are no medical conditions or diseases under investigation, participants are healthy volunteers. |
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E.1.1.2 | Therapeutic area | Not possible to specify |
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 |
The primary objective of the study is to study the effects of intranasal OT (vs. placebo) administration to mothers on their neural and behavioral responsivity to children’s emotional signals
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the study is to study the effects of intranasal OT (vs. placebo) administration to mothers on approach-avoidance motivational responses to own vs. unfamiliar child stimuli after contextual priming cues |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet the following criteria: -healthy female subjects -20-40 years old -mothers of children younger than 12 months |
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria during a telephone prescreening will be excluded from participation in this study: -Breastfeeding -Any known neurological, visual, and auditory impairment -Use of medication (except oral contraceptives) -Drug or alcohol abuse -Psychiatric disorder -Nasal disease or obstruction -Smoking -Pregnancy -Cardiovascular disease |
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E.5 End points |
E.5.1 | Primary end point(s) |
-Event-related potential responses to child and adult facial expression stimuli (N1, N170, EPN, P3, LPP) -Manual reaction times to detect the appearance of a face in the continuous flash suppression paradigm
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Participants will come to the laboratory for two identical experimental sessions, separated by 4 weeks. |
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E.5.2 | Secondary end point(s) |
-Asymmetric electroencephalogram (EEG) activity within the alpha frequency band over frontal electrode sites to own and unfamiliar child stimuli.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary parameters will be assessed during the same two identical experimental sessions, separated by 4 weeks. |
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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 |
The proposed research project will investigate the role of oxytocin in maternal neurocognitive responses to child signals |
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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 | 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
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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 | 9 |
E.8.9.1 | In the Member State concerned days | 0 |