Trial Outcomes & Findings for Preventing Postpartum Depression With Intranasal Oxytocin (NCT NCT02505984)

Last Updated: 2025-02-25

Results Overview

Day 5 postpartum: Self-report assessment of maternal bonding (Maternal Attachment Inventory, higher scores means better outcome, range 26 -104) 2 months postpartum: Quantitative observational assessment of mother-infant bonding (Coding Interactive Behavior; mean score represents mean score of the study sample. Negative bonding includes age-appropriate items on maternal intrusiveness, infant withdrawal, and dyad negative sub-scales, higher scores indicate higher levels of negative bonding behavior (deviation above the mean represent worse outcome); positive bonding includes maternal sensitivity, maternal limit setting, infant involvement, and dyad reciprocity sub-scales, higher scores indicate higher levels of bonding behavior, deviation above the mean represent better outcome); and repeat of self-report (MAI)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

5 days and 2 months postpartum (on average)

Results posted on

2025-02-25

Participant Flow

Participants were recruited from Massachusetts General Hospital Outpatient Obstetrics Clinic between January 2016 and December 2019. The first participant was enrolled on January 8, 2016, and the last participant was enrolled on December 4, 2019.

Of 56 enrolled participants, 42 were randomized to treatment.

Participant milestones

Participant milestones
Measure	Oxytocin Sub-group of participants receiving oxytocin nasal spray (Syntocinon) Oxytocin: Study participants will be randomized to a placebo or drug group.	Placebo Sub-group of participants receiving placebo nasal spray Placebo: Study participants will be randomized to a placebo or drug group.
Overall Study STARTED	20	22
Overall Study COMPLETED	18	20
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxytocin Sub-group of participants receiving oxytocin nasal spray (Syntocinon) Oxytocin: Study participants will be randomized to a placebo or drug group.	Placebo Sub-group of participants receiving placebo nasal spray Placebo: Study participants will be randomized to a placebo or drug group.
Overall Study Enrolled in study under IRB Other Event (depression screening score below inclusion criteria)	1	0
Overall Study Unreliable self-report data	1	0
Overall Study Study blind opened during assessment	0	1
Overall Study Noncompliance with study protocol	0	1

Baseline Characteristics

Preventing Postpartum Depression With Intranasal Oxytocin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxytocin n=20 Participants Sub-group of participants receiving oxytocin nasal spray (Syntocinon) Oxytocin: Study participants will be randomized to a placebo or drug group.	Placebo n=22 Participants Sub-group of participants receiving placebo nasal spray Placebo: Study participants will be randomized to a placebo or drug group.	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.75 years STANDARD_DEVIATION 5.27 • n=5 Participants	32.59 years STANDARD_DEVIATION 6.11 • n=7 Participants	31.71 years STANDARD_DEVIATION 5.73 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Asian American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	22 participants n=7 Participants	42 participants n=5 Participants
Screening Edinburgh Postnatal Depression Scale Score	13.25 score on a scale STANDARD_DEVIATION 3.73 • n=5 Participants	13.23 score on a scale STANDARD_DEVIATION 3.44 • n=7 Participants	13.24 score on a scale STANDARD_DEVIATION 3.53 • n=5 Participants

PRIMARY outcome

Timeframe: 5 days and 2 months postpartum (on average)

Outcome measures

Outcome measures
Measure	Oxytocin n=18 Participants Sub-group of participants receiving oxytocin nasal spray (Syntocinon) Oxytocin: Study participants will be randomized to a placebo or drug group.	Placebo n=20 Participants Sub-group of participants receiving placebo nasal spray Placebo: Study participants will be randomized to a placebo or drug group.
Treatment Effect on Mother-infant Bonding Maternal bonding, 5 days postpartum	99.33 score on a scale Standard Deviation 6.15	99.35 score on a scale Standard Deviation 6.92
Treatment Effect on Mother-infant Bonding Maternal bonding, 2 months postpartum	101.11 score on a scale Standard Deviation 5.58	97.90 score on a scale Standard Deviation 7.28
Treatment Effect on Mother-infant Bonding Mother-infant bonding, 2 months postpartum (Observed, negative bonding, Z score)	-0.22 score on a scale Standard Deviation 0.81	0.20 score on a scale Standard Deviation 0.50
Treatment Effect on Mother-infant Bonding Mother-infant bonding, 2 months postpartum (Observed, positive bonding, Z score)	0.19 score on a scale Standard Deviation 0.82	-0.17 score on a scale Standard Deviation 0.59

SECONDARY outcome

Timeframe: Baseline and 5 days postpartum

Self-reported assessment of severity of maternal depression symptoms (Edinburgh Postnatal Depression Scale, higher scores mean worse outcome, range 0 - 30).

Outcome measures

Outcome measures
Measure	Oxytocin n=18 Participants Sub-group of participants receiving oxytocin nasal spray (Syntocinon) Oxytocin: Study participants will be randomized to a placebo or drug group.	Placebo n=20 Participants Sub-group of participants receiving placebo nasal spray Placebo: Study participants will be randomized to a placebo or drug group.
Treatment Effect on Maternal Depression Symptoms Maternal depression, pregnancy	13.22 score on a scale Standard Deviation 2.98	13.35 score on a scale Standard Deviation 3.53
Treatment Effect on Maternal Depression Symptoms Maternal depression, 5 days postpartum	7.72 score on a scale Standard Deviation 5.12	9.45 score on a scale Standard Deviation 5.49

SECONDARY outcome

Timeframe: Baseline and 5 days postpartum

Self-reported severity of maternal anxiety symptoms (Brief Symptom Inventory, Anxiety sub-scale, higher scores means worse outcome, range 0 - 24).

Outcome measures

Outcome measures
Measure	Oxytocin n=18 Participants Sub-group of participants receiving oxytocin nasal spray (Syntocinon) Oxytocin: Study participants will be randomized to a placebo or drug group.	Placebo n=20 Participants Sub-group of participants receiving placebo nasal spray Placebo: Study participants will be randomized to a placebo or drug group.
Treatment Effect on Maternal Anxiety Symptoms Maternal anxiety, pregnancy	5.67 score on a scale Standard Deviation 5.55	6.95 score on a scale Standard Deviation 5.77
Treatment Effect on Maternal Anxiety Symptoms Maternal anxiety, 5 days postpartum	5.44 score on a scale Standard Deviation 6.71	6.30 score on a scale Standard Deviation 6.74

SECONDARY outcome

Timeframe: 2 months postpartum (on average)

Quantitative observational assessment of infant communication, cognitive, and motor development (Bayley Scales of Infant Development, screening, higher scores better outcome, ranges for each subscale are reported for infants 1-6 months old (items are scored either 0 or 1) - communication scale range 0-4, cognitive scale range 0-7, motor scale range 0-12; note: Bayley Scales can be performed for up to 42 months old infants; developmentally advanced infants may achieve scores above the reported range scale above)

Outcome measures

Outcome measures
Measure	Oxytocin n=18 Participants Sub-group of participants receiving oxytocin nasal spray (Syntocinon) Oxytocin: Study participants will be randomized to a placebo or drug group.	Placebo n=20 Participants Sub-group of participants receiving placebo nasal spray Placebo: Study participants will be randomized to a placebo or drug group.
Child Development Infant communication subscale, 2 months postpartum	3.44 score on a scale Standard Deviation 0.78	3.55 score on a scale Standard Deviation 0.69
Child Development Infant cognition subscale, 2 months postpartum	5.19 score on a scale Standard Deviation 1.21	5.61 score on a scale Standard Deviation 1.30
Child Development Infant motor subscale, 2 months postpartum	6.88 score on a scale Standard Deviation 3.24	7.73 score on a scale Standard Deviation 3.11

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oxytocin n=20 participants at risk Sub-group of participants receiving oxytocin nasal spray (Syntocinon) Oxytocin: Study participants will be randomized to a placebo or drug group.	Placebo n=22 participants at risk Sub-group of participants receiving placebo nasal spray Placebo: Study participants will be randomized to a placebo or drug group.
Reproductive system and breast disorders Uterine Cramping	5.0% 1/20 • Number of events 1 • 14 weeks (on average) Study drug diary asked participants to report and list symptoms experienced, if applicable.	4.5% 1/22 • Number of events 1 • 14 weeks (on average) Study drug diary asked participants to report and list symptoms experienced, if applicable.
Respiratory, thoracic and mediastinal disorders Slight nosebleeding	10.0% 2/20 • Number of events 6 • 14 weeks (on average) Study drug diary asked participants to report and list symptoms experienced, if applicable.	4.5% 1/22 • Number of events 1 • 14 weeks (on average) Study drug diary asked participants to report and list symptoms experienced, if applicable.
Nervous system disorders Headache	0.00% 0/20 • 14 weeks (on average) Study drug diary asked participants to report and list symptoms experienced, if applicable.	4.5% 1/22 • Number of events 1 • 14 weeks (on average) Study drug diary asked participants to report and list symptoms experienced, if applicable.
Cardiac disorders Chest tightness	0.00% 0/20 • 14 weeks (on average) Study drug diary asked participants to report and list symptoms experienced, if applicable.	4.5% 1/22 • Number of events 1 • 14 weeks (on average) Study drug diary asked participants to report and list symptoms experienced, if applicable.

Additional Information

Dr. Sharon Dekel

Massachusetts General Hospital

Phone: 617-726-1352

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place