There are no medical conditions or diseases under investigation MedDRA version: 18.1 Level: LLT Classification code 10047146 Term: Vasopressin System Organ Class: 10022891 - Investigations MedDRA version: 18.1 Level: PT Classification code 10033329 Term: Oxytocin System Organ Class: 10022891 - Investigations
Conditions
Sponsors
Universiteit Leiden
Eligibility
Sex/Gender
Male
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Timepoint(s) of evaluation of this end point: Participants will come to the laboratory for three identical experimental sessions, seperated by 1 weeks.;Secondary Objective: 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). ;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 s | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Participants will come to the laboratory for three identical experimental sessions, seperated by 1 weeks.;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). | — |
Countries
Netherlands
Contacts
Public ContactSecretary's Office
Universiteit Leiden
Outcome results
None listed