Testing the Efficacy of Intranasal Oxytocin for the Prevention of Postpartum Depression and PTSD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Treatment Effect on Mother-infant Bonding
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Third-trimester pregnant women being followed at the Massachusetts General Hospital (MGH) Obstetrics Program
- •At risk of postpartum depression (PPD)
排除标准
- •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
研究组 & 干预措施
Oxytocin
Sub-group of participants receiving oxytocin nasal spray (Syntocinon)
干预措施: Oxytocin (Drug)
Placebo
Sub-group of participants receiving placebo nasal spray
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment Effect on Mother-infant Bonding
时间窗: 5 days and 2 months postpartum (on average)
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)
次要结局
- Treatment Effect on Maternal Depression Symptoms(Baseline and 5 days postpartum)
- Treatment Effect on Maternal Anxiety Symptoms(Baseline and 5 days postpartum)
- Child Development(2 months postpartum (on average))
研究者
Sharon Dekel, PhD
Assistant Professor in Psychology
Massachusetts General Hospital
