Primary outcomeMean· Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in Ventral Tegmental Area (VTA)
| Group | Value (Percent signal change) | Spread |
|---|---|---|
| Oxytocin | 0.54 | 1.24 |
| Placebo | 0.27 | 1.34 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataNeurobiological Bases of Paternal Nurturance
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 35 participants (actual)
- Sponsor
- James K. Rilling, PhD · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- Aug 2014
- Primary completion
- Feb 2016
- Completion
- Feb 2016
- First posted
- 22 Aug 2014 (estimated)
- Last update posted
- 5 Jun 2017
- Conditions
- Healthy
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2014201520162017
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The overall goal of this project is to identify the genetic, hormonal, and neurobiological influences on paternal nurturing behavior and to determine if fathers' neural responses to infants can be modulated by neuropeptides known to play a role in parenting in experimental animal models. The aim is to determine if pharmacological manipulation of central oxytocin (OT) and vasopressin (AVP) levels influences the neural response to viewing pictures of one's own infant or to hearing cry stimuli. In a double-blind procedure, fathers with 1-3 year old children will be scanned on two separate occasions; once under the influence of OT/AVP and once under the influence of placebo. Fathers will be randomized to either OT or AVP, and order of administration of drug and placebo will counterbalanced across subjects. Fathers will be scanned while viewing pictures of their own and an unknown child and while listening to unknown infant cry stimuli. The investigators hypothesize: * OT will augment the ventral tegmental area (VTA), ventral striatum and medial orbitofrontal cortex (mOFC) response to viewing pictures of one's own child, and will augment the primary auditory cortex (AI) response of fathers to infant cries. * AVP will augment the lateral septum response to viewing own child pictures.
Interventions
- OxytocinDrug
- VasopressinDrug
- PlaceboDrug
Arms2
Experimental
OT + placebo
The OT + placebo group will self-administer no more than 1 ml solution of oxytocin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo will counterbalanced across subjects, such that half will receive OT first, and half will receive OT second.
Experimental
AVP + placebo
The AVP + placebo group will self-administer no more than 1 ml solution of vasopressin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo will counterbalanced across subjects, such that half will receive AVP first, and half will receive AVP second.
Primary outcomes6
Outcomes the sponsor listed as primary.
Mean Percent Signal Change in Ventral Tegmental Area (VTA)
Time frame · Baseline, Visit 2 (Up to 10 days)
Registry description
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.
Mean Percent Signal Change in Right Ventral Striatum
Time frame · Baseline, Visit 2 (Up to 10 days)
Registry description
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.
Mean Percent Signal Change in Right Medial Orbitofrontal Cortex
Time frame · Baseline, Visit 2 (Up to 10 days)
Registry description
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.
Mean Percent Signal Change in Caudate Nucleus
Time frame · Baseline, Visit 2 (Up to 10 days)
Registry description
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
Mean Percent Signal Change in the Visual Cortex
Time frame · Baseline, Visit 2 (Up to 10 days)
Registry description
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
Mean Percent Signal Change in the Anterior Cingulate Cortex
Time frame · Baseline, Visit 2 (Up to 10 days)
Registry description
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
Secondary outcomes(6)
Change in Plasma Levels of Vasopressin (AVP)
Time frame · Baseline, Visit 2 (Up to 10 days)
Registry description
Peripheral levels of AVP will be assessed via assay of plasma collected.
Change in Plasma Levels of Oxytocin (OT)
Time frame · Baseline, Visit 2 (Up to 10 days)
Registry description
Peripheral levels of OT will be assessed via assay of plasma collected.
Difference in Cry Rating Scores Between OT and Placebo
Time frame · Baseline, Visit 2 (Up to 10 days)
Registry description
The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under OT and placebo treatment on a 7-point likert scale. Sixteen adjectives will be used to describe two different cries. Participants will rate each cry from 1-7 where one represents "not at all" and 7 represents "extremely". Difference is defined as OT minus placebo scores.
Difference in Cry Rating Scores Between AVP and Placebo
Time frame · Baseline, Visit 2 (Up to 10 days)
Registry description
The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under AVP and placebo treatment on a 7-point likert scale. Sixteen adjectives will be used to describe two different cries. Participants will rate each cry from 1-7 where one represents "not at all" and 7 represents "extremely". Difference is defined as AVP minus placebo scores.
Mean Percent Signal Change in Primary Auditory Cortex
Time frame · Baseline, Visit 2 (Up to 10 days)
Registry description
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.
Mean Percent Signal Change in Right Lateral Septum
Time frame · Baseline, Visit 2 (Up to 10 days)
Registry description
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between AVP treatment and placebo treatments (AVP-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the AVP group only per protocol.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in Right Ventral Striatum
| Group | Value (Percent signal change) | Spread |
|---|---|---|
| Oxytocin | -1.28 | 1.59 |
| Placebo | -0.81 | 1.74 |
Primary outcomeMean· Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in Right Medial Orbitofrontal Cortex
| Group | Value (Percent signal change) | Spread |
|---|---|---|
| Oxytocin | -0.22 | 0.64 |
| Placebo | -0.53 | 0.96 |
Primary outcomeMean· Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in Caudate Nucleus
| Group | Value (Percent signal change) | Spread |
|---|---|---|
| Oxytocin | 0.85 | 0.92 |
| Placebo | -0.27 | 0.67 |
Primary outcomeMean· Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in the Visual Cortex
| Group | Value (Percent signal change) | Spread |
|---|---|---|
| Oxytocin | 0.83 | 1.18 |
| Placebo | 0.10 | 1.34 |
Primary outcomeMean· Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in the Anterior Cingulate Cortex
| Group | Value (Percent signal change) | Spread |
|---|---|---|
| Oxytocin | 0.27 | 0.60 |
| Placebo | -0.39 | 0.63 |
Secondary and other outcome results(2)
Secondary outcome· Baseline, Visit 2 (Up to 10 days)
Change in Plasma Levels of Vasopressin (AVP)
| Group | Value |
|---|---|
| AVP + Placebo | not posted |
Secondary outcome· Baseline, Visit 2 (Up to 10 days)
Change in Plasma Levels of Oxytocin (OT)
| Group | Value |
|---|---|
| OT + Placebo Group | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| OT TreatmentThe OT group self-administered no more than 1 ml solution of oxytocin in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. This group also went through the Placebo of OT treatment. | 0 / 16 | 0 / 16 | 2 / 16 |
| AVP TreatmentThe AVP group self-administered no more than 1 ml solution of vasopressin in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. This group also went through the Placebo of AVP treatment. | 0 / 16 | 0 / 16 | 3 / 16 |
| Placebo of OTThe placebo of OT group self-administered no more than 1 ml solution of placebo of OT in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. This group also went through the OT treatment. | 0 / 16 | 0 / 16 | 2 / 16 |
| Placebo of AVPThe placebo of AVP group self-administered no more than 1 ml solution of placebo of AVP in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. This group also went through the AVP treatment. | 0 / 16 | 0 / 16 | 0 / 16 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* above 18
* biological fathers of 1-3 year old infants who are currently cohabitating with the child's mother
* normal or corrected-to-normal vision of 20/40
Exclusion Criteria:
* current or past history of mental illness
* active medical or neurological disorder
* current or past history of alcohol or drug dependence
* claustrophobic (at the discretion of the PI with subject consultation)
* history of seizures or other neurological disorder
* history of hypertension, cardiovascular disease, nephritis, diabetes or other endocrine diseases or malignancy
* ferrous metal in any part of the body
* history of asthma or migraine headaches (can be included at the discretion of the study physician or nurse practitioner if episodes are infrequent and no active problems at time of study, not medicated)
* history of head trauma or psychiatric illness, as well as those who are receiving or have received over the past year, medication with known psychoactive effects (included at the discretion of the PI as these are exclusion criteria due to data quality concerns and not safety concerns; head trauma should be minimal enough deemed by the PI)
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