Studies of Mothers With Postnatal Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in maternal mood
研究概览
简要总结
This study investigates the effects of a single dose of oxytocin (OT) delivered via a nasal spray in women with and without traits of postnatal depression (PND).
详细描述
A double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design will be conducted.
Participants will include mothers and their infant in the postnatal period. All participants will be screened for symptoms of low mood on the Edinburgh Postnatal Depression Scale (EPDS) and then assigned into 2 groups comprising probable PND cases and controls.
All participants will take part in 3 conditions at Baseline (before nasal spray administration), Condition 1 (after first OT/Placebo administration) and Condition 2 (after second OT/Placebo administration), and will complete the same order of tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All mothers will be aged ≥18 years old.
- •Mothers in the clinical group will score above the clinical cut-off point on the EPDS.
- •Mothers in the control group will score below the clinical cut-off point on the EPDS.
- •Mothers must be able to read and write English at a level sufficient to complete study related assessments.
排除标准
- •If the mother is younger than 18 or post-menopausal
- •If the pregnancy was a result of fertility treatment
- •If the mother is pregnant
- •If the mother has history of psychotic illness
- •If the mother is at risk of self-harm
- •If the mother is involved in other active drug trials
结局指标
主要结局
Change in maternal mood
时间窗: Baseline, 35-45 minutes after intervention administration
Change in maternal mood will be assessed using the PANAS questionnaire
次要结局
- Change in mother-infant interactional style(Baseline, 35-45 minutes after intervention administration)
- Change in maternal OT(Baseline, 35-45 minutes after intervention administration)
- Change in infant OT(Baseline, 35-45 minutes after intervention administration)
- Change in maternal mindmindedness(Baseline, 35-45 minutes after intervention administration)
- Maternal gaze during interaction with her infant(35-45 minutes after intervention administration)