Trial Outcomes & Findings for Neurobiological Bases of Paternal Nurturance (NCT NCT02223429)
NCT ID: NCT02223429
Last Updated: 2017-06-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Baseline, Visit 2 (Up to 10 days)
Results posted on
2017-06-05
Participant Flow
Enrollment took place from 9/29/2014 through 2/3/2016.
Of the 35 participants consented for participation, 32 began the study. Three participants were lost to follow up after signing the consent form.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neurobiological Bases of Paternal Nurturance
Baseline characteristics by cohort
| Measure |
OT First, Followed by Placebo
n=7 Participants
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.
|
Placebo First, Followed by OT
n=8 Participants
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.
|
AVP First, Followed by Placebo
n=8 Participants
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.
|
Placebo First, Followed by AVP
n=8 Participants
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.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.14 years
STANDARD_DEVIATION 4.14 • n=5 Participants
|
31.88 years
STANDARD_DEVIATION 4.61 • n=7 Participants
|
32.25 years
STANDARD_DEVIATION 5.75 • n=5 Participants
|
34 years
STANDARD_DEVIATION 4.75 • n=4 Participants
|
32.81 years
STANDARD_DEVIATION 4.70 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
31 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Visit 2 (Up to 10 days)Population: The analysis was completed per protocol for the OT + placebo groups only.
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.
Outcome measures
| Measure |
Oxytocin
n=15 Participants
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.
|
Placebo
n=15 Participants
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.
|
|---|---|---|
|
Mean Percent Signal Change in Ventral Tegmental Area (VTA)
|
0.54 Percent signal change
Standard Deviation 1.24
|
0.27 Percent signal change
Standard Deviation 1.34
|
PRIMARY outcome
Timeframe: Baseline, Visit 2 (Up to 10 days)Population: The analysis was completed per protocol for the OT + placebo groups only.
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.
Outcome measures
| Measure |
Oxytocin
n=15 Participants
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.
|
Placebo
n=15 Participants
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.
|
|---|---|---|
|
Mean Percent Signal Change in Right Ventral Striatum
|
-1.28 Percent signal change
Standard Deviation 1.59
|
-0.81 Percent signal change
Standard Deviation 1.74
|
PRIMARY outcome
Timeframe: Baseline, Visit 2 (Up to 10 days)Population: The analysis was completed per protocol for the OT + placebo groups only.
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.
Outcome measures
| Measure |
Oxytocin
n=15 Participants
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.
|
Placebo
n=15 Participants
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.
|
|---|---|---|
|
Mean Percent Signal Change in Right Medial Orbitofrontal Cortex
|
-0.22 Percent signal change
Standard Deviation 0.64
|
-0.53 Percent signal change
Standard Deviation 0.96
|
PRIMARY outcome
Timeframe: Baseline, Visit 2 (Up to 10 days)Population: The analysis was completed per protocol for the OT + placebo groups only.
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).
Outcome measures
| Measure |
Oxytocin
n=15 Participants
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.
|
Placebo
n=15 Participants
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.
|
|---|---|---|
|
Mean Percent Signal Change in Caudate Nucleus
|
0.85 Percent signal change
Standard Deviation 0.92
|
-0.27 Percent signal change
Standard Deviation 0.67
|
PRIMARY outcome
Timeframe: Baseline, Visit 2 (Up to 10 days)Population: The analysis was completed per protocol for the OT + placebo groups only.
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).
Outcome measures
| Measure |
Oxytocin
n=15 Participants
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.
|
Placebo
n=15 Participants
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.
|
|---|---|---|
|
Mean Percent Signal Change in the Visual Cortex
|
0.83 Percent signal change
Standard Deviation 1.18
|
0.10 Percent signal change
Standard Deviation 1.34
|
PRIMARY outcome
Timeframe: Baseline, Visit 2 (Up to 10 days)Population: Analysis was conducted in the OT+placebo groups only.
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).
Outcome measures
| Measure |
Oxytocin
n=15 Participants
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.
|
Placebo
n=15 Participants
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.
|
|---|---|---|
|
Mean Percent Signal Change in the Anterior Cingulate Cortex
|
0.27 Percent signal change
Standard Deviation 0.60
|
-0.39 Percent signal change
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline, Visit 2 (Up to 10 days)Population: Zero participants were analyzed as AVP samples were not assayed.
Peripheral levels of AVP will be assessed via assay of plasma collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Visit 2 (Up to 10 days)Population: Zero participants were analyzed as samples were not assayed.
Peripheral levels of OT will be assessed via assay of plasma collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Visit 2 (Up to 10 days)Population: 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.
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.
Outcome measures
| Measure |
Oxytocin
n=14 Participants
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.
|
Placebo
n=14 Participants
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.
|
|---|---|---|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Grating
|
3.71 units on a scale
Standard Deviation 1.90
|
4.64 units on a scale
Standard Deviation 1.60
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Urgent
|
4.29 units on a scale
Standard Deviation 1.94
|
4.86 units on a scale
Standard Deviation 1.66
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Piercing
|
4.29 units on a scale
Standard Deviation 1.86
|
4.36 units on a scale
Standard Deviation 1.78
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Aversive
|
3.57 units on a scale
Standard Deviation 1.74
|
3.36 units on a scale
Standard Deviation 1.45
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Compelling
|
4.57 units on a scale
Standard Deviation 1.79
|
5.00 units on a scale
Standard Deviation 1.92
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Manipulative
|
2.86 units on a scale
Standard Deviation 1.92
|
2.29 units on a scale
Standard Deviation 1.38
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Spoiled
|
2.14 units on a scale
Standard Deviation 1.10
|
2.07 units on a scale
Standard Deviation .92
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Irritated
|
3.07 units on a scale
Standard Deviation 1.86
|
3.29 units on a scale
Standard Deviation 1.98
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Sympathetic
|
4.71 units on a scale
Standard Deviation 1.50
|
4.43 units on a scale
Standard Deviation 1.65
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Alarmed
|
4.21 units on a scale
Standard Deviation 2.00
|
4.07 units on a scale
Standard Deviation 2.20
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Angry
|
2.43 units on a scale
Standard Deviation 1.83
|
2.57 units on a scale
Standard Deviation 1.79
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Upset
|
3.07 units on a scale
Standard Deviation 1.90
|
3.29 units on a scale
Standard Deviation 2.30
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Compassionate
|
4.86 units on a scale
Standard Deviation 2.07
|
5.14 units on a scale
Standard Deviation 1.56
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Distressed
|
3.57 units on a scale
Standard Deviation 2.24
|
3.64 units on a scale
Standard Deviation 1.91
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Annoyed
|
2.43 units on a scale
Standard Deviation 1.65
|
2.43 units on a scale
Standard Deviation 1.51
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 1 Tender
|
3.79 units on a scale
Standard Deviation 1.63
|
3.64 units on a scale
Standard Deviation 1.82
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Grating
|
3.43 units on a scale
Standard Deviation 2.17
|
3.79 units on a scale
Standard Deviation 1.93
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Urgent
|
4.93 units on a scale
Standard Deviation 1.54
|
4.43 units on a scale
Standard Deviation 2.07
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Piercing
|
3.71 units on a scale
Standard Deviation 2.23
|
4.00 units on a scale
Standard Deviation 2.32
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Aversive
|
3.50 units on a scale
Standard Deviation 1.83
|
4.07 units on a scale
Standard Deviation 1.39
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Compelling
|
5.21 units on a scale
Standard Deviation 1.37
|
5.14 units on a scale
Standard Deviation 1.56
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Manipulative
|
2.43 units on a scale
Standard Deviation 2.03
|
2.36 units on a scale
Standard Deviation 1.74
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Spoiled
|
2.00 units on a scale
Standard Deviation 1.41
|
2.00 units on a scale
Standard Deviation 1.36
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Irritated
|
2.21 units on a scale
Standard Deviation 1.53
|
2.36 units on a scale
Standard Deviation 1.69
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Sypmathetic
|
5.86 units on a scale
Standard Deviation 1.17
|
5.64 units on a scale
Standard Deviation 1.45
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Alarmed
|
4.36 units on a scale
Standard Deviation 2.34
|
4.57 units on a scale
Standard Deviation 2.17
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Angry
|
1.79 units on a scale
Standard Deviation 1.05
|
1.79 units on a scale
Standard Deviation .98
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Upset
|
2.86 units on a scale
Standard Deviation 1.56
|
2.57 units on a scale
Standard Deviation 1.40
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Compassionate
|
5.71 units on a scale
Standard Deviation 1.49
|
5.43 units on a scale
Standard Deviation 1.70
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Distressed
|
3.36 units on a scale
Standard Deviation 2.17
|
3.86 units on a scale
Standard Deviation 2.21
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Annoyed
|
2.00 units on a scale
Standard Deviation 1.30
|
1.93 units on a scale
Standard Deviation 1.44
|
|
Difference in Cry Rating Scores Between OT and Placebo
Cry 2 Tender
|
4.50 units on a scale
Standard Deviation 1.22
|
4.79 units on a scale
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: Baseline, Visit 2 (Up to 10 days)Population: Analysis was completed according to protocol for all participants who were administered AVP in combination with placebo at any time point during the study.
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.
Outcome measures
| Measure |
Oxytocin
n=16 Participants
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.
|
Placebo
n=16 Participants
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.
|
|---|---|---|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Compelling
|
4.56 units on a scale
Standard Deviation 1.32
|
5.00 units on a scale
Standard Deviation 1.21
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Manipulative
|
3.06 units on a scale
Standard Deviation 1.48
|
2.69 units on a scale
Standard Deviation 1.49
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Spoiled
|
2.44 units on a scale
Standard Deviation 1.03
|
1.94 units on a scale
Standard Deviation 1.06
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Irritated
|
3.44 units on a scale
Standard Deviation 1.82
|
3.44 units on a scale
Standard Deviation 1.86
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Sympathetic
|
5.06 units on a scale
Standard Deviation 1.81
|
4.38 units on a scale
Standard Deviation 2.09
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Alarmed
|
4.88 units on a scale
Standard Deviation 1.46
|
4.38 units on a scale
Standard Deviation 1.41
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Angry
|
1.94 units on a scale
Standard Deviation 1.44
|
1.81 units on a scale
Standard Deviation 1.22
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Upset
|
3.00 units on a scale
Standard Deviation 1.55
|
2.63 units on a scale
Standard Deviation 1.20
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Grating
|
3.25 units on a scale
Standard Deviation 1.69
|
3.38 units on a scale
Standard Deviation 1.78
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Urgent
|
5.13 units on a scale
Standard Deviation 1.26
|
5.25 units on a scale
Standard Deviation 0.78
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Compassionate
|
4.88 units on a scale
Standard Deviation 1.71
|
4.94 units on a scale
Standard Deviation 1.65
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Distressed
|
3.31 units on a scale
Standard Deviation 1.35
|
3.31 units on a scale
Standard Deviation 1.58
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Annoyed
|
2.50 units on a scale
Standard Deviation 1.67
|
2.25 units on a scale
Standard Deviation 1.48
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Tender
|
4.00 units on a scale
Standard Deviation 1.51
|
4.19 units on a scale
Standard Deviation 1.56
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Grating
|
4.69 units on a scale
Standard Deviation 1.45
|
4.06 units on a scale
Standard Deviation 1.611
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Urgent
|
5.44 units on a scale
Standard Deviation 1.09
|
5.31 units on a scale
Standard Deviation 1.01
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Piercing
|
4.81 units on a scale
Standard Deviation 1.47
|
4.19 units on a scale
Standard Deviation 1.33
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 1 Aversive
|
3.94 units on a scale
Standard Deviation 1.48
|
3.81 units on a scale
Standard Deviation 1.38
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Piercing
|
3.13 units on a scale
Standard Deviation 1.10
|
3.56 units on a scale
Standard Deviation 1.50
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Aversive
|
3.44 units on a scale
Standard Deviation 1.55
|
3.44 units on a scale
Standard Deviation 1.09
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Compelling
|
4.50 units on a scale
Standard Deviation 1.63
|
5.00 units on a scale
Standard Deviation 0.97
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Manipulative
|
2.63 units on a scale
Standard Deviation 2.06
|
2.38 units on a scale
Standard Deviation 1.46
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Spoiled
|
2.19 units on a scale
Standard Deviation 1.33
|
2.31 units on a scale
Standard Deviation 1.40
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Irritated
|
2.13 units on a scale
Standard Deviation 1.50
|
2.63 units on a scale
Standard Deviation 1.46
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Sypmathetic
|
4.88 units on a scale
Standard Deviation 1.75
|
4.94 units on a scale
Standard Deviation 1.69
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Alarmed
|
4.31 units on a scale
Standard Deviation 1.74
|
4.25 units on a scale
Standard Deviation 1.69
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Angry
|
2.13 units on a scale
Standard Deviation 1.63
|
2.00 units on a scale
Standard Deviation 1.16
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Upset
|
3.19 units on a scale
Standard Deviation 1.91
|
2.88 units on a scale
Standard Deviation 1.59
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Compassionate
|
4.88 units on a scale
Standard Deviation 1.75
|
4.75 units on a scale
Standard Deviation 1.84
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Distressed
|
3.06 units on a scale
Standard Deviation 1.77
|
3.06 units on a scale
Standard Deviation 1.53
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Annoyed
|
2.19 units on a scale
Standard Deviation 1.68
|
1.88 units on a scale
Standard Deviation 1.26
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Cry 2 Tender
|
4.44 units on a scale
Standard Deviation 1.10
|
4.50 units on a scale
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Baseline, Visit 2 (Up to 10 days)Population: The analysis was completed per protocol for the OT + placebo group only.
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.
Outcome measures
| Measure |
Oxytocin
n=15 Participants
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.
|
Placebo
n=15 Participants
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.
|
|---|---|---|
|
Mean Percent Signal Change in Primary Auditory Cortex
|
0.10 Percent signal change
Standard Deviation 0.15
|
0.10 Percent signal change
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: Baseline, Visit 2 (Up to 10 days)Population: 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.
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.
Outcome measures
| Measure |
Oxytocin
n=14 Participants
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.
|
Placebo
n=14 Participants
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.
|
|---|---|---|
|
Mean Percent Signal Change in Right Lateral Septum
|
0.19 Percent signal change
Standard Deviation 0.43
|
0.36 Percent signal change
Standard Deviation 0.56
|
Adverse Events
OT Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AVP Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo of OT
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo of AVP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OT Treatment
n=16 participants at risk
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.
|
AVP Treatment
n=16 participants at risk
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.
|
Placebo of OT
n=16 participants at risk
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.
|
Placebo of AVP
n=16 participants at risk
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.
|
|---|---|---|---|---|
|
Psychiatric disorders
Claustrophobia
|
6.2%
1/16 • Number of events 1 • Adverse events were collected throughout the duration of the study (2 years).
|
0.00%
0/16 • Adverse events were collected throughout the duration of the study (2 years).
|
0.00%
0/16 • Adverse events were collected throughout the duration of the study (2 years).
|
0.00%
0/16 • Adverse events were collected throughout the duration of the study (2 years).
|
|
Vascular disorders
High Blood Pressure prior to Drug Administration
|
6.2%
1/16 • Number of events 1 • Adverse events were collected throughout the duration of the study (2 years).
|
0.00%
0/16 • Adverse events were collected throughout the duration of the study (2 years).
|
12.5%
2/16 • Number of events 2 • Adverse events were collected throughout the duration of the study (2 years).
|
0.00%
0/16 • Adverse events were collected throughout the duration of the study (2 years).
|
|
Nervous system disorders
Headache prior to Drug Administration
|
0.00%
0/16 • Adverse events were collected throughout the duration of the study (2 years).
|
6.2%
1/16 • Number of events 1 • Adverse events were collected throughout the duration of the study (2 years).
|
0.00%
0/16 • Adverse events were collected throughout the duration of the study (2 years).
|
0.00%
0/16 • Adverse events were collected throughout the duration of the study (2 years).
|
|
Product Issues
Nasal Spray Strength Intolerance
|
0.00%
0/16 • Adverse events were collected throughout the duration of the study (2 years).
|
12.5%
2/16 • Number of events 2 • Adverse events were collected throughout the duration of the study (2 years).
|
0.00%
0/16 • Adverse events were collected throughout the duration of the study (2 years).
|
0.00%
0/16 • Adverse events were collected throughout the duration of the study (2 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place