Trial · Interventional

CompletedPhase 2Results postedRegistry data

Preventing Postpartum Depression With Intranasal Oxytocin

Short name IN-OXT

NCTNCT02505984Other id2015P001100Other id224421Other id225686Other id1R21HD090396-01A1

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 56 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Jan 2016
Primary completion: May 2023
Completion: May 2023
First posted: 22 Jul 2015 (estimated)
Last update posted: 25 Feb 2025
Conditions: Depression, Postpartum · Anxiety

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20162018202020222024

Ph 2
IN-OXT
NCT02505984
Jan 2016 to May 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to test a new treatment for preventing childbirth-related mental illness in postpartum mothers. The treatment is aimed at enhancing maternal bonding, reducing postpartum depression (PPD) and anxiety in mothers at risk, and promoting child development. To this end, the investigators will test the clinical utility of intranasal (IN) oxytocin (OXT) administered to mothers during the first postpartum days.

Interventions

OxytocinDrug
PlaceboDrug

Arms2

Active comparator
Oxytocin
Sub-group of participants receiving oxytocin nasal spray (Syntocinon)
Placebo comparator
Placebo
Sub-group of participants receiving placebo nasal spray

Primary outcomes1

Outcomes the sponsor listed as primary.

Treatment Effect on Mother-infant Bonding
Time frame · 5 days and 2 months postpartum (on average)
Registry description
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)

Secondary outcomes(3)

Treatment Effect on Maternal Depression Symptoms
Time frame · Baseline and 5 days postpartum
Registry description
Self-reported assessment of severity of maternal depression symptoms (Edinburgh Postnatal Depression Scale, higher scores mean worse outcome, range 0 - 30).
Treatment Effect on Maternal Anxiety Symptoms
Time frame · Baseline and 5 days postpartum
Registry description
Self-reported severity of maternal anxiety symptoms (Brief Symptom Inventory, Anxiety sub-scale, higher scores means worse outcome, range 0 - 24).
Child Development
Time frame · 2 months postpartum (on average)
Registry description
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)

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· 5 days and 2 months postpartum (on average)

Treatment Effect on Mother-infant Bonding

Group	Value (score on a scale)	Spread
Oxytocin	99.33	6.15
Placebo	99.35	6.92

Secondary and other outcome results(3)

Secondary outcomeMean· Baseline and 5 days postpartum

Treatment Effect on Maternal Depression Symptoms

Group	Value (score on a scale)	Spread
Oxytocin	13.22	2.98
Placebo	13.35	3.53

Secondary outcomeMean· Baseline and 5 days postpartum

Treatment Effect on Maternal Anxiety Symptoms

Group	Value (score on a scale)	Spread
Oxytocin	5.67	5.55
Placebo	6.95	5.77

Secondary outcomeMean· 2 months postpartum (on average)

Child Development

Group	Value (score on a scale)	Spread
Oxytocin	3.44	0.78
Placebo	3.55	0.69

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
OxytocinSub-group of participants receiving oxytocin nasal spray (Syntocinon) Oxytocin: Study participants will be randomized to a placebo or drug group.	0 / 20	0 / 20	3 / 20
PlaceboSub-group of participants receiving placebo nasal spray Placebo: Study participants will be randomized to a placebo or drug group.	0 / 22	0 / 22	3 / 22

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

Studies6

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Meta-analysis (pooled) · 2024

Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms.

Bertolini et al. 2024The Cochrane database of systematic reviewscited by 4

PMID 38767196PMC11103774DOI 10.1002/14651858.cd013613.pub2PUB-38767196

Rights unknown

Source link

More studies

5 studies on this page

PubMed tag: none · 2016

Oxytocin course over pregnancy and postpartum period and the association with postpartum depressive symptoms.

Jobst et al. 2016Archives of women's mental healthcited by 57

PMID 27320943DOI 10.1007/s00737-016-0644-2PUB-27320943

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 2015

Oxytocin promotes protective behavior in depressed mothers: a pilot study with the enthusiastic stranger paradigm.

Mah et al. 2015Depression and anxietycited by 54

PMID 24523054DOI 10.1002/da.22245PUB-24523054

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 2011

Corrected

Oxytocin modulates amygdala, insula, and inferior frontal gyrus responses to infant crying: a randomized controlled trial.

Riem et al. 2011Biological psychiatrycited by 269

PMID 21470595DOI 10.1016/j.biopsych.2011.02.006PUB-21470595

Rights unknown

Source link Read the notice

PubMed tag: none · 2011

Plasma oxytocin concentration during pregnancy is associated with development of postpartum depression.

Skrundz et al. 2011Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacologycited by 226

PMID 21562482PMC3154107DOI 10.1038/npp.2011.74PUB-21562482

Rights unknown

Source link

Indexing hint: Randomized controlled trial · 2006

Randomised, double blind trial of oxytocin nasal spray in mothers expressing breast milk for preterm infants.

Fewtrell et al. 2006Archives of disease in childhood. Fetal and neonatal editioncited by 52

PMID 16223754PMC2672698DOI 10.1136/adc.2005.081265PUB-16223754

Rights unknown

Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedBertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2. PMID 35141873

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Third-trimester pregnant women being followed at the Massachusetts General Hospital (MGH) Obstetrics Program * At risk of postpartum depression (PPD) Exclusion Criteria: * Failure to participate in regular prenatal check-ups * Current diagnosis Diagnostic and Statistical Manual of Mental Disorders (DSM-5) mental disorder pertaining to psychosis or substance abuse * Suicidality * Obstetric complication (e.g., preeclampsia, excessive hemorrhaging) * Use of potentially confounding or interacting medications * Complicating pediatric medical condition in the newborn

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