Phase 2
Completed N=42
Preventing Postpartum Depression With Intranasal Oxytocin
Depression, Postpartum · Anxiety
Source: ClinicalTrials.gov NCT02505984 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Treatment Effect on Mother-infant Bonding — 99.33; 99.35; 101.11; 97.90 score on a scale — p=0.5
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Effect on Mother-infant Bonding |
99.33; 99.35; 101.11; 97.90; -0.22; 0.20 | 0.5 |
| SECONDARY Treatment Effect on Maternal Depression Symptoms |
13.22; 13.35; 7.72; 9.45 | >0.9 |
| SECONDARY Treatment Effect on Maternal Anxiety Symptoms |
5.67; 6.95; 5.44; 6.30 | 0.5 |
| SECONDARY Child Development |
3.44; 3.55; 5.19; 5.61; 6.88; 7.73 | 0.7 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02505984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.