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. |
|
E.1.1.1 | Medical condition in easily understood language |
There are no medical conditions or diseases under investigation,
participants are healthy volunteers. |
|
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 objectives of the study are to study the effects of intranasal OT (vs. placebo) administration to mothers on:
1. Mothers' observed interaction behavior
2. Children's sensitivity to the emotional signals of others (via OT-induced effects on mothers' interactive behavior) |
|
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 specific facets of interactive behaviors with one's own child |
|
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:
Mothers: healthy female subjects, 20-40 years old, mothers of children
younger than 9 months
Children: healthy infants, approximately 9 months old during
the first laboratory visit |
|
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
For the children:
-Premature birth (<37 weeks)
-Low birth weight (<2500 g)
-Diagnosis of a neurological or visual disorder |
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Maternal sensitivity scores on the Emotional Availability Scales during
mother-child free play
-Infant saccadic responses to peripheral visual stimuli in the eyetracking
paradigm |
|
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. |
|
E.5.2 | Secondary end point(s) |
-Maternal responses in the focal interaction tasks (indicating contingent
responsiveness, responses to joint attention cues, and emotionregulatory
behaviors) |
|
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. |
|
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 maternal interactive behavior and infants' processing of emotional facial expressions. |
|
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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |