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 |
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E.1.1.1 | Medical condition in easily understood language |
There are no medical conditions or diseases under investigation |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033329 |
E.1.2 | Term | Oxytocin |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 |
Primary Objectives: -To investigate with observational and electrophysiological techniques mothers' defensive reactivity in contexts where their infant is associated with a minor threat and modulation of such reactivity by intranasal oxytocin administration. -To investigate whether oxytocin administration increases mothers and grandmothers' sensitivity towards their children and grandchildren. |
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E.2.2 | Secondary objectives of the trial |
Secondary Objectives: -To measure concordance in mothers' and grandmothers' salivary oxytocin levels in the oxytocin and placebo conditions and to also measure infants' salivary oxytocin levels in response to putative differences in caregiving sensitivity by the mother and grandmother in the oxytocin vs. placebo conditions. -To assess the mothers' and grandmothers' attachment representations of one another and the potential modulation of such representations by oxytocin administration. |
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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 all of the following criteria: -Mothers: healthy female subjects, 25-40 years old -Grandmothers: healthy female subjects, 50-65 years old -Infants: healthy infants, 5-6 months old during the first laboratory visit |
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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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
There are three main study parameters. First, we will use EEG to measure neural responses to own vs. unfamiliar infant's images after priming the images with threat-related vs. neutral prime stimuli. EEG will be analyzed with respect to asymmetric activity within the alpha frequency band over frontal electrode sites. Second, video recordings of the Enthusiastic Stranger Paradigm will focus on the mothers' defensive and protective responses such as signs of vigilance and concern, as well as more direct verbal or behavioral attempts to interrupt the stranger. Third, standard procedures will be followed to measure mothers' and grandmothers' caregiving sensitivity in the oxytocin vs. placebo conditions. |
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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) |
First, in the EEG task, we will also analyze attention-related event-related potentials (ERPs) in response to the infant stimuli. While ERPs are not as direct measures of motivational approach tendencies as frontal EEG asymmetry, they can importantly complement the EEG asymmetry data by potentially revealing oxytocin-induced differences in ERPs reflecting the strength of automatic attention orienting to the infant stimuli. Second, saliva samples will be collected three times during the lab visit to measure whether a) oxytocin levels in saliva show a reliable increase after oxytocin administration, b) the amount of increase in salivary oxytocin is similar in mothers and grandmothers, and c) the expected differences in caregiving sensitivity by the mother and grandmother in the oxytocin vs. placebo conditions are accompanied by differential salivary oxytocin responses in the infants. Third, the mother and the grandmother are also administered the Experiences in Close Relationships-Relationship Structures (ECR-RS; Fraley, Heffernan, Vicary, & Brumbaugh, 2011) questionnaire to assess their attachment representations toward each other and to analyze whether such representations are affected by oxytocin. |
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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 defensive responses, maternal interactive behavior, and grandparent-grandchild interactions. |
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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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LVLS: 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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |