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| ID | Type | Description | Link |
|---|---|---|---|
| 224421 | Other Grant/Funding Number | Claflin Distinguished Scholar Award | |
| 225686 | Other Grant/Funding Number | Brain & Behavior Research Foundation | |
| 1R21HD090396-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
Postpartum depression (PPD) is a debilitating disorder which imposes a threat to mother and infant health. An estimated 600,000 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 mother's 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Active Comparator | Sub-group of participants receiving oxytocin nasal spray (Syntocinon) |
|
| Placebo | Placebo Comparator | Sub-group of participants receiving placebo nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Study participants will be randomized to a placebo or drug group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Effect on Mother-infant Bonding | 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) | 5 days and 2 months postpartum (on average) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Effect on Maternal Depression Symptoms | Self-reported assessment of severity of maternal depression symptoms (Edinburgh Postnatal Depression Scale, higher scores mean worse outcome, range 0 - 30). | Baseline and 5 days postpartum |
| Treatment Effect on Maternal Anxiety Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Dekel, PhD | Massachusetts General Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hosptial | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24523054 | Background | Mah BL, Bakermans-Kranenburg MJ, Van IJzendoorn MH, Smith R. Oxytocin promotes protective behavior in depressed mothers: a pilot study with the enthusiastic stranger paradigm. Depress Anxiety. 2015 Feb;32(2):76-81. doi: 10.1002/da.22245. Epub 2014 Feb 12. | |
| 21562482 | Background | Skrundz M, Bolten M, Nast I, Hellhammer DH, Meinlschmidt G. Plasma oxytocin concentration during pregnancy is associated with development of postpartum depression. Neuropsychopharmacology. 2011 Aug;36(9):1886-93. doi: 10.1038/npp.2011.74. Epub 2011 May 11. |
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Of 56 enrolled participants, 42 were randomized to treatment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin | Sub-group of participants receiving oxytocin nasal spray (Syntocinon) Oxytocin: Study participants will be randomized to a placebo or drug group. |
| FG001 | Placebo | Sub-group of participants receiving placebo nasal spray Placebo: Study participants will be randomized to a placebo or drug group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin | Sub-group of participants receiving oxytocin nasal spray (Syntocinon) Oxytocin: Study participants will be randomized to a placebo or drug group. |
| BG001 | Placebo | Sub-group of participants receiving placebo nasal spray Placebo: Study participants will be randomized to a placebo or drug group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Effect on Mother-infant Bonding | 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) | Posted | Mean | Standard Deviation | score on a scale | 5 days and 2 months postpartum (on average) |
|
14 weeks (on average)
Study drug diary asked participants to report and list symptoms experienced, if applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin | Sub-group of participants receiving oxytocin nasal spray (Syntocinon) Oxytocin: Study participants will be randomized to a placebo or drug group. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine Cramping | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharon Dekel | Massachusetts General Hospital | 617-726-1352 | sdekel@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 13, 2021 | Dec 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 27, 2024 | Dec 30, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 15, 2024 | Dec 26, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Drug | Study participants will be randomized to a placebo or drug group. |
|
|
Self-reported severity of maternal anxiety symptoms (Brief Symptom Inventory, Anxiety sub-scale, higher scores means worse outcome, range 0 - 24). |
| Baseline and 5 days postpartum |
| Child Development | 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) | 2 months postpartum (on average) |
| 16223754 | Background | Fewtrell MS, Loh KL, Blake A, Ridout DA, Hawdon J. Randomised, double blind trial of oxytocin nasal spray in mothers expressing breast milk for preterm infants. Arch Dis Child Fetal Neonatal Ed. 2006 May;91(3):F169-74. doi: 10.1136/adc.2005.081265. Epub 2005 Oct 13. |
| 21470595 | Background | Riem MM, Bakermans-Kranenburg MJ, Pieper S, Tops M, Boksem MA, Vermeiren RR, van Ijzendoorn MH, Rombouts SA. Oxytocin modulates amygdala, insula, and inferior frontal gyrus responses to infant crying: a randomized controlled trial. Biol Psychiatry. 2011 Aug 1;70(3):291-7. doi: 10.1016/j.biopsych.2011.02.006. Epub 2011 Apr 5. |
| 27320943 | Background | Jobst A, Krause D, Maiwald C, Hartl K, Myint AM, Kastner R, Obermeier M, Padberg F, Brucklmeier B, Weidinger E, Kieper S, Schwarz M, Zill P, Muller N. Oxytocin course over pregnancy and postpartum period and the association with postpartum depressive symptoms. Arch Womens Ment Health. 2016 Aug;19(4):571-9. doi: 10.1007/s00737-016-0644-2. Epub 2016 Jun 20. |
| 38767196 | Derived | Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2. |
| 35141873 | Derived | Bertolini 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. |
| Study blind opened during assessment |
|
| Noncompliance with study protocol |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Screening Edinburgh Postnatal Depression Scale Score | Self-reported assessment of severity of maternal depression symptoms (higher scores mean worse outcome, range 0 - 30). | Mean | Standard Deviation | score on a scale |
|
Sub-group of participants receiving oxytocin nasal spray (Syntocinon)
Oxytocin: Study participants will be randomized to a placebo or drug group.
| OG001 | Placebo | Sub-group of participants receiving placebo nasal spray Placebo: Study participants will be randomized to a placebo or drug group. |
|
|
|
| Secondary | Treatment Effect on Maternal Depression Symptoms | Self-reported assessment of severity of maternal depression symptoms (Edinburgh Postnatal Depression Scale, higher scores mean worse outcome, range 0 - 30). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 5 days postpartum |
|
|
|
|
| Secondary | Treatment Effect on Maternal Anxiety Symptoms | Self-reported severity of maternal anxiety symptoms (Brief Symptom Inventory, Anxiety sub-scale, higher scores means worse outcome, range 0 - 24). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 5 days postpartum |
|
|
|
|
| Secondary | Child Development | 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 | Mean | Standard Deviation | score on a scale | 2 months postpartum (on average) |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 3 |
| 20 |
| EG001 | Placebo | Sub-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 |
| Slight nosebleeding | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Chest tightness | Cardiac disorders | Systematic Assessment | Participant reported tightness in chest (unknown effect) after 1 dose; she was unsure if related to nasal spray. Event reported to Institutional Review Board (expedited review). Study blind was opened and identified participant as randomized placebo. |
|
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Superiority |
| Superiority |
| Infant motor subscale, 2 months postpartum |
|
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.4 | Superiority |