Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Occurrence of Major depressive episode
研究概览
简要总结
Postpartum depression is a serious illness that affects approximately 17% of women who have recently given birth. Untreated depression appears to have negative effects for both the mother and her baby. Postpartum depression is quite common among women with a history of depression. Sleeplessness is a common concern during pregnancy and after delivery, and it can also trigger depression in women with a history of depression. Antidepressants are the most commonly recommended drugs for prevention of postpartum depression; however, there is limited research to understand the effectiveness of the medications in preventing postpartum depression. Trazodone is a weak antidepressant, but it is commonly prescribed for sleeplessness due to physical or psychiatric disorders. We are planning a study to find out whether trazodone in a low dose is more effective than a sugar pill in preventing postpartum depression among women with histories of depression. We expect the results of our study will make it easier for healthcare providers to select the right medication for women who are at risk of developing depression after delivery and thus improve the mental health of mothers and well-being of their babies.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy outpatients with a history of Major depressive disorder who are currently not on any psychotropic medications and who:
- •are 18- 45 years old,
- •are pregnant with gestation of 28-34 weeks,
- •have been in full remission of depression for > 2 months (as per Diagnostic and Statistical Manual-5),
- •are able to communicate in English,
- •are capable of providing informed consent,
- •are planning to deliver at Victoria Hospital in London Ontario, and
- •live in London and the surrounding area, will be enrolled.
排除标准
- •current psychiatric disorder other than generalized anxiety,
- •use of psychotropic medication over the previous 2 months,
- •history of bipolar disorder or psychosis,
- •high risk for suicide (actively suicidal or a score of ≥ 3 on item #3 on the Hamilton Depression Rating Scale-17 item [HDRS]),
- •currently receiving psychotherapy
研究组 & 干预措施
Trazodone
Trazodone once daily for 24 weeks.
干预措施: Trazodone (Drug)
Placebo
Placebo once daily for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of Major depressive episode
时间窗: 27 weeks
Participants having a score of \>7 on the Hamilton Depression Rating Scale (Max 52) will be assessed using the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders- 5 (SCID-5) to establish recurrence of an major depressive episode. A higher score indicates recurrence of an MDE
次要结局
- Time to occurrence of Major Depressive Episode (MDE)(27 weeks)
- Blood pressure(27 weeks)
- Body weight(27 weeks)
- Side effects(27 weeks)
- Development of mania symptoms(27 weeks)
- Electrocardiogram QT Interval(27 weeks)
- Hamilton Depression Rating Scale(24 weeks)
- Edinburgh Postnatal Depression(24 weeks)
- Maternal Functioning(27 weeks)
- Pulse(27 weeks)
- Pill count(27 weeks)
- Retention rate(27 weeks)
- Complete blood count (CBC)(27 weeks)
- Thyroid Stimulating Hormone test(27 weeks)
研究者
Verinder Sharma
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's