A Dietary Supplement for Mood Symptoms in Early Postpartum: A Double Blind Randomized Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood in postpartum as compared to placebo.
详细描述
This double blind placebo controlled randomized trial will evaluate the effect of administration of a dietary supplement (DS) on the intensity of postpartum blues. It is expected that the administration will result in less sadness in day-5 postpartum women after negative mood induction in those receiving the dietary supplement compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
all are blinded
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 45
- •BMI 19 to 40 (kg/m2)
- •Resting pulse between 45 and 100 bpm
- •Systolic blood pressure between 91 and 139 mmHg (inclusive)
- •Diastolic blood pressure between 51 and 90 mmHg (inclusive)
- •Orthostatic blood pressure change <20 mmHg (based on the difference between supine and standing (1 minute) systolic blood pressure)
排除标准
- •The subject has been diagnosed with any axis 1 and 2 disorders based on Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) interview within the past 10 years.
- •Subjects who have been smoking cigarettes in the past 5 years (to reduce variability in mood attributable to cigarette withdrawal and monoamine oxidase A (MAO-A)).
- •Intolerance to any of the components of the intervention.
- •If in the principal investigator's judgement the obstetric or neonatal complications were so severe that would cause change in the results of the study, such as infant death, the subject will be excluded.
结局指标
主要结局
Change in Visual Analog Scale (VAS)
时间窗: Assessment will be done on day-5 postpartum. On the assessment day, the VAS will be administered before and after sad mood induction and compared]
VAS uses a 10-cm scale for participants to indicate the extent to which each of them feel happy or sad. The change in VAS before versus after sad mood induction is the change score in VAS. The change score on the day with active dietary supplement is compare to the change score of the subjects who have received placebo
次要结局
- Change in Profile of Mood States (POMS) Scores(Assessment will be done on day-5 postpartum. On the assessment day, the POMS will be administered before and after sad mood induction and compared])
研究者
Jeff Meyer
Program Head, Neurochemical Imaging for Mood Disorders
Centre for Addiction and Mental Health