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 | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047146 |
E.1.2 | Term | Vasopressin |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
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 |
In a series of randomized control trials (RCTs) the following hypothesis will be tested: Intranasal administration of oxytocin and vasopressin affect neural and behavioral responses to infant signals and threat to the infant. • Oxytocin and vasopressin modulate activation in the ‘parental brain’ systems related to arousal, reflexive care, and cognitive/empathic processing. • Oxytocin will increase connectivity of the amygdala with prefrontal regions, and vasopressin will increase amygdala connectivity with the brainstem. • Oxytocin will promote an affiliative response to threat to the infant, and vasopressin will promote an defensive response.
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E.2.2 | Secondary objectives of the trial |
This study has two secondary objectives. First, we will examine the extent to which effects of oxytocin and vasopressin are moderated by father’s ‘early childhood experiences’. Second, oxytocin, vasopressin, testosterone, and estradiol levels will be assessed in saliva and blood. Vasopressin and oxytocin levels will be measured to examine cross-reactions (oxytocin-vasopressin). Testosterone and estradiol levels will be measured to examine mechanisms (testosterone – estradiol – oxytocin; testosterone - vasopressin).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In each phase of parenthood (prenatal (child age = -3 months), early postnatal (child age = + 2 months), late postnatal (child age = + 7 months), 40 fathers having their first baby will be recruited to take part in the study. |
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Not living in the same house as their partner Endocrine disorders Smoking Alcohol and drug abuse Use of medication potentially interfering with the endocrine system MRI contraindications, including metallic foreign objects, neurological disorder and claustrophobia Psychiatric disorder Cardiovascular disease Nose injuries and disorders
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E.5 End points |
E.5.1 | Primary end point(s) |
The first main study parameter is activity in brain areas associated with (1) arousal/salience (amygdala, ventral striatum), (2) reflexive care (hypothalamus), (3) emotion regulation (insula, medial prefrontal cortex, anterior cingulate cortex), and cognitive / empathic processing (insula, inferior frontal and orbitofrontal gyri, temporoparietal junction). We will examine the effects of oxytocin and vasopressin on activity in these areas in fathers during “processing infant signals” and “processing threat to infant” tasks designed to elicit protective responses (affiliative versus defensive response). The second main study parameter is parenting behavior, including “handgrip during infant cry”, (Bakermans-Kranenburg, van IJzendoorn, Riem, Tops, & Alink, 2012) sensitivity (“quality of care” task), involvement (“quantity of care task”), and protection (“Enthusiastic Stranger Paradigm”, (Mah, Bakermans-Kranenburg, Van, & Smith, 2015). We will examine the effects of oxytocin and vasopressin on these parenting behaviors.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Participants will come to the laboratory for three identical experimental sessions, seperated by 1 weeks. |
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E.5.2 | Secondary end point(s) |
• We will examine the extent to which effects of oxytocin and vasopressin are moderated by father’s ‘early childhood experiences’. • Oxytocin, vasopressin, testosterone, and estradiol levels will be assessed in saliva and blood. Vasopressin and oxytocin levels will be measured to examine cross-reactions (oxytocin-vasopressin). Testosterone and estradiol levels will be measured to examine mechanisms (testosterone – estradiol – oxytocin; testosterone - vasopressin).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Participants will come to the laboratory for three identical experimental sessions, seperated by 1 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 |
With the proposed study we aim to gain insights into the effects of oxytocin and vasopressin on paternal quality of care, quantity of care, and offspring protection. |
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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 | 3 |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |