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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD078778 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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:
30 fathers of children aged 1-3 will participate in two functional imaging sequence (fMRI) sessions, once under the influence of OT/AVP, and once under the influence of placebo. Fathers will be restricted to men who are living with their biological child and an adult partner (male or female) that they are in a committed relationship with. All fathers will receive two fMRI scans on two different occasions, separated by 2-10 days. 15 fathers will be randomized to intranasal OT, the other 15 will be randomized to intranasal AVP. Within each drug group, the order of administration of drug and placebo will counterbalanced across subjects, such that 15 will receive OT/AVP first, and 15 will receive OT/AVP second. During the fMRI scans, fathers will view pictures of their own and unknown children, as well as unknown adults. Afterwards, while still in the scanner, they will listen to infant cry and control stimuli. After exiting the scanner, fathers will again listen to the cry stimuli and will rate their emotional reaction to the cry stimuli on the following dimensions using a 7 point likert scale: irritated, sympathetic, alarmed, angry, upset, compassionate, distressed, annoyed, and tender.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OT + placebo | Experimental | 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. |
|
| AVP + placebo | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Signal Change in Ventral Tegmental Area (VTA) | 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. | Baseline, Visit 2 (Up to 10 days) |
| Mean Percent Signal Change in Right Ventral Striatum | 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. | Baseline, Visit 2 (Up to 10 days) |
| Mean Percent Signal Change in Right Medial Orbitofrontal Cortex | 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. | Baseline, Visit 2 (Up to 10 days) |
| Mean Percent Signal Change in Caudate Nucleus | 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). | Baseline, Visit 2 (Up to 10 days) |
| Mean Percent Signal Change in the Visual Cortex | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plasma Levels of Vasopressin (AVP) | Peripheral levels of AVP will be assessed via assay of plasma collected. | Baseline, Visit 2 (Up to 10 days) |
| Change in Plasma Levels of Oxytocin (OT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James K Rilling, Ph.D. | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30307 | United States | ||
| Emory University 1462 Clifton Rd |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15004563 | Background | Hamann S, Herman RA, Nolan CL, Wallen K. Men and women differ in amygdala response to visual sexual stimuli. Nat Neurosci. 2004 Apr;7(4):411-6. doi: 10.1038/nn1208. Epub 2004 Mar 7. |
| Label | URL |
|---|---|
| Related Info | View source |
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Of the 35 participants consented for participation, 32 began the study. Three participants were lost to follow up after signing the consent form.
Enrollment took place from 9/29/2014 through 2/3/2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | OT First, Followed by Placebo | Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days. |
| FG001 | Placebo First, Followed by OT | Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days. |
| FG002 | AVP First, Followed by Placebo | Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days. |
| FG003 | Placebo First, Followed by AVP | Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only participants who completed the study were included in the baseline analysis. Among the 32 subjects who started the study, one participant did not complete MRI scanning and was not included in any data analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | OT First, Followed by Placebo | Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percent Signal Change in Ventral Tegmental Area (VTA) | 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. | The analysis was completed per protocol for the OT + placebo groups only. | Posted | Mean | Standard Deviation | Percent signal change | Baseline, Visit 2 (Up to 10 days) |
|
Adverse events were collected throughout the duration of the study (2 years).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OT Treatment | The 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Claustrophobia | Psychiatric disorders | Systematic Assessment |
Plasma levels of vasopressin (AVP) and peripheral levels of oxytocin (OT) were not assayed due to lack of funding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Rilling | Emory University | 404-727-3062 | jrillin@emory.edu |
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| ID | Term |
|---|---|
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D014667 | Vasopressins |
| D001127 | Arginine Vasopressin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Vasopressin | Drug | 1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays |
|
|
| Placebo | Drug | 1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays |
|
| Baseline, Visit 2 (Up to 10 days) |
| Mean Percent Signal Change in the Anterior Cingulate Cortex | 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). | Baseline, Visit 2 (Up to 10 days) |
Peripheral levels of OT will be assessed via assay of plasma collected.
| Baseline, Visit 2 (Up to 10 days) |
| Difference in Cry Rating Scores Between OT and Placebo | 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. | Baseline, Visit 2 (Up to 10 days) |
| Difference in Cry Rating Scores Between AVP and Placebo | 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. | Baseline, Visit 2 (Up to 10 days) |
| Mean Percent Signal Change in Primary Auditory Cortex | 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. | Baseline, Visit 2 (Up to 10 days) |
| Mean Percent Signal Change in Right Lateral Septum | 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. | Baseline, Visit 2 (Up to 10 days) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Placebo First, Followed by OT |
Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days. |
| BG002 | AVP First, Followed by Placebo | Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days. |
| BG003 | Placebo First, Followed by AVP | Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo |
Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days. |
|
|
| Primary | Mean Percent Signal Change in Right Ventral Striatum | 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. | The analysis was completed per protocol for the OT + placebo groups only. | Posted | Mean | Standard Deviation | Percent signal change | Baseline, Visit 2 (Up to 10 days) |
|
|
|
| Primary | Mean Percent Signal Change in Right Medial Orbitofrontal Cortex | 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. | The analysis was completed per protocol for the OT + placebo groups only. | Posted | Mean | Standard Deviation | Percent signal change | Baseline, Visit 2 (Up to 10 days) |
|
|
|
| Primary | Mean Percent Signal Change in Caudate Nucleus | 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). | The analysis was completed per protocol for the OT + placebo groups only. | Posted | Mean | Standard Deviation | Percent signal change | Baseline, Visit 2 (Up to 10 days) |
|
|
|
| Primary | Mean Percent Signal Change in the Visual Cortex | 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). | The analysis was completed per protocol for the OT + placebo groups only. | Posted | Mean | Standard Deviation | Percent signal change | Baseline, Visit 2 (Up to 10 days) |
|
|
|
| Primary | Mean Percent Signal Change in the Anterior Cingulate Cortex | 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). | Analysis was conducted in the OT+placebo groups only. | Posted | Mean | Standard Deviation | Percent signal change | Baseline, Visit 2 (Up to 10 days) |
|
|
|
| Secondary | Change in Plasma Levels of Vasopressin (AVP) | Peripheral levels of AVP will be assessed via assay of plasma collected. | Zero participants were analyzed as AVP samples were not assayed. | Posted | Baseline, Visit 2 (Up to 10 days) |
|
|
| Secondary | Change in Plasma Levels of Oxytocin (OT) | Peripheral levels of OT will be assessed via assay of plasma collected. | Zero participants were analyzed as samples were not assayed. | Posted | Baseline, Visit 2 (Up to 10 days) |
|
|
| Secondary | Difference in Cry Rating Scores Between OT and Placebo | 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. | Of the 15 participants who were administered oxytocin in combination with placebo at any time point during the study, data were analyzed for 14 participants. One participant was excluded from the analysis due to missing data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Visit 2 (Up to 10 days) |
|
|
|
| Secondary | Difference in Cry Rating Scores Between AVP and Placebo | 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. | Analysis was completed according to protocol for all participants who were administered AVP in combination with placebo at any time point during the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Visit 2 (Up to 10 days) |
|
|
|
| Secondary | Mean Percent Signal Change in Primary Auditory Cortex | 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. | The analysis was completed per protocol for the OT + placebo group only. | Posted | Mean | Standard Deviation | Percent signal change | Baseline, Visit 2 (Up to 10 days) |
|
|
|
| Secondary | Mean Percent Signal Change in Right Lateral Septum | 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. | The analysis was conducted in the AVP groups only per protocol. One person from each order of administration were excluded from the analysis due to motion issues in their imaging data. | Posted | Mean | Standard Deviation | Percent signal change | Baseline, Visit 2 (Up to 10 days) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | AVP Treatment | The 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 |
| EG002 | Placebo of OT | The 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 |
| EG003 | Placebo of AVP | The 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 |
| High Blood Pressure prior to Drug Administration | Vascular disorders | Systematic Assessment |
|
| Headache prior to Drug Administration | Nervous system disorders | Systematic Assessment |
|
| Nasal Spray Strength Intolerance | Product Issues | Systematic Assessment | Participants reported that the vasopressin nasal spray was too strong. The brand was subsequently changed. |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009479 | Neuropeptides |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| Cry 1 Piercing |
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| Cry 1 Aversive |
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| Cry 1 Compelling |
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| Cry 1 Manipulative |
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| Cry 1 Spoiled |
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| Cry 1 Irritated |
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| Cry 1 Sympathetic |
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| Cry 1 Alarmed |
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| Cry 1 Angry |
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| Cry 1 Upset |
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| Cry 1 Compassionate |
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| Cry 1 Distressed |
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| Cry 1 Annoyed |
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| Cry 1 Tender |
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| Cry 2 Grating |
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| Cry 2 Urgent |
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| Cry 2 Piercing |
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| Cry 2 Aversive |
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| Cry 2 Compelling |
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| Cry 2 Manipulative |
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| Cry 2 Spoiled |
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| Cry 2 Irritated |
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| Cry 2 Sypmathetic |
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| Cry 2 Alarmed |
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| Cry 2 Angry |
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| Cry 2 Upset |
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| Cry 2 Compassionate |
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| Cry 2 Distressed |
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| Cry 2 Annoyed |
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| Cry 2 Tender |
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| Cry 1 Piercing |
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| Cry 1 Aversive |
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| Cry 1 Compelling |
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| Cry 1 Manipulative |
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| Cry 1 Spoiled |
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| Cry 1 Irritated |
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| Cry 1 Sympathetic |
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| Cry 1 Alarmed |
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| Cry 1 Angry |
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| Cry 1 Upset |
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| Cry 1 Compassionate |
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| Cry 1 Distressed |
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| Cry 1 Annoyed |
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| Cry 1 Tender |
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| Cry 2 Grating |
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| Cry 2 Urgent |
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| Cry 2 Piercing |
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| Cry 2 Aversive |
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| Cry 2 Compelling |
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| Cry 2 Manipulative |
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| Cry 2 Spoiled |
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| Cry 2 Irritated |
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| Cry 2 Sypmathetic |
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| Cry 2 Alarmed |
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| Cry 2 Angry |
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| Cry 2 Upset |
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| Cry 2 Compassionate |
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| Cry 2 Distressed |
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| Cry 2 Annoyed |
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| Cry 2 Tender |
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