Intranasal Oxytocin: A Neuropharmacological Intervention for Maternal Neglect?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers
研究概览
简要总结
The investigators plan to conduct functional MRI scanning with a group of mothers who are blindly and randomly assigned either intranasal oxytocin or a placebo. The purpose of this investigation is to explore how oxytocin may modify early maternal brain and behavioral responses to infant cues. This study will examine, for the first time, a potential pharmacological intervention for maternal neglect which targets core neurobiological deficits. This may eventually be used to supplement and augment other psychosocial and behavioral interventions.
In addition, the investigators will examine sex differences in parental brain and behavioral responses to oxytocin by also recruiting fathers to participate in a similar protocol.
详细描述
The investigators plan to conduct fMRI scanning with a group of mothers who are blindly and randomly assigned either intranasal oxytocin or a placebo.
Aim 1: To determine whether intranasal oxytocin (IN-OT) affects parental brain responses to infant cues, as measured during functional MRI (fMRI) scanning.
Hypothesis 1 (i): Compared to placebo, mothers who receive intranasal oxytocin will show greater activation of mesocorticolimbic dopamine reward regions in the brain, including the ventral striatum and the medial prefrontal cortex, when viewing their own vs. unknown infant faces during fMRI scanning. Hypothesis 1 (ii): Compared to placebo, fathers will show greater activation of social-cognitive circuits, including the dorsal prefrontal cortex (dPFC).
Aim 2: To determine whether IN-OT affects parental behavioral responses to infant cues, as measured by videotaped parent-infant interaction procedures.
Hypothesis 2 (i): Compared to placebo, parents who receive intranasal oxytocin will score higher on an overall measure of maternal sensitivity, during a free play parent-infant interaction procedure (CARE-Index). Hypothesis 2 (ii): Compared to placebo, mothers who receive intranasal oxytocin will demonstrate more frequent emotionally contingent responses with their infant during the recovery phase of a modified Still-Face procedure.
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to fulfill enrollment criteria, the women must:
- •be first-time parent(s)
- •who have just delivered a term infant >37 weeks gestation, without medical complications.
- •She should be:
- •aged between 20 and 45 years;
- •and be English speaking from childhood (required for accurate coding of attachment interview).
- •For male partners:
- •First-time fathers;
- •have female partners who just delivered a term infant >37 weeks gestation, without medical complications;
- •aged between 20 and 45 years;
- •English speaking from childhood
排除标准
- •Those who meet the following, will be excluded:
- •History of head injury resulting in loss of consciousness for >10 minutes;
- •neurological disease, including stroke, brain tumor, meningitis or encephalitis;
- •any contraindications to MRI scanning, e.g. pacemakers, aneurysm clips, neurostimulators, fixed hearing devices, metal in eyes, or other implants;
- •previous inability to tolerate MRI scanning procedure, or claustrophobia; and
- •a past history of drug addiction or serious psychopathology, other than anxiety or depression.
研究组 & 干预措施
Oxytocin
Intranasal oxytocin (24IU) given 50 minutes prior to behavior assessment or scanning
干预措施: Intranasal Oxytocin (Drug)
Oxytocin
Intranasal oxytocin (24IU) given 50 minutes prior to behavior assessment or scanning
干预措施: Functional MRI scanning (Procedure)
Placebo
Intranasal placebo spray given 50 minutes prior to behavior assessment or scanning
干预措施: Placebo (Drug)
Placebo
Intranasal placebo spray given 50 minutes prior to behavior assessment or scanning
干预措施: Functional MRI scanning (Procedure)
结局指标
主要结局
Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers
时间窗: 30 minutes after intranasal spray is administered
We will compare the BOLD signal of regions in the brain (including the ventral striatum, caudate, putamen, amygdala, and the medial prefrontal cortex) in mothers who receive intranasal oxytocin, compared to placebo. In every analysis, we measure the difference in brain response (BOLD signal) between viewing the mother's own infant (O) more than unknown infant (U) faces (O\>U), during fMRI scanning.
次要结局
未报告次要终点
研究者
Robin Kochel
Associate Professor
Baylor College of Medicine