Ignite Creation Date:
2024-05-06 @ 7:18 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02505984
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2015-07-19
Brief Title:
Preventing Postpartum Depression With Intranasal Oxytocin
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Testing the Efficacy of Intranasal Oxytocin for the Prevention of Postpartum Depression and PTSD
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IN-OXT
Brief 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
Detailed Description:
Postpartum depression PPD is a debilitating disorder which imposes a threat to mother and infant health An estimated 600000 American women suffer from PPD annually making it one of the most frequent complications of pregnancy Available secondary preventive interventions are often ineffective which calls for identifying novel means for prevention Impaired mother-infant bonding is a hallmark of PPD Depressed mothers may have difficulties developing maternal feelings and providing sensitive care In turn impaired bonding may worsen mothers depression Conventional pharmacotherapy does not help with bonding impairment
This study will attempt to fill in the current gap in effective preventive interventions for pregnant mothers at risk Evidence in postpartum mothers indicates that high peripartum OXT levels are associated with enhanced maternal behavior and low levels with depression Data also indicates that in depressed mothers OXT levels may decrease during the first days following childbirth rather than increase as is the norm Therefore the investigators will test the therapeutic effects of OXT in women at risk for PPD It is hypothesized that administration of IN-OXT total daily dose 48 IU over the course of four days from as early as day one postpartum in comparison to placebo will 1 enhance mother-infant bonding 2 reduce depressive and anxiety symptoms at 5 days postpartum and 3 facilitate child development
This study will attempt to fill in the current gap in effective preventive interventions for pregnant mothers at risk Evidence in postpartum mothers indicates that high peripartum OXT levels are associated with enhanced maternal behavior and low levels with depression Data also indicates that in depressed mothers OXT levels may decrease during the first days following childbirth rather than increase as is the norm Therefore the investigators will test the therapeutic effects of OXT in women at risk for PPD It is hypothesized that administration of IN-OXT total daily dose 48 IU over the course of four days from as early as day one postpartum in comparison to placebo will 1 enhance mother-infant bonding 2 reduce depressive and anxiety symptoms at 5 days postpartum and 3 facilitate child development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 224421 | OTHER_GRANT | None | None |
| 225686 | OTHER_GRANT | None | None |
| 1R21HD090396-01A1 | NIH | Brain Behavior Research Foundation | httpsreporternihgovquickSearch1R21HD090396-01A1 |