A Pilot Study on the Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Recruitment and retention rate
研究概览
简要总结
Postpartum depression is a serious disorder that affects approximately 14% of women who have recently given birth. Postpartum depression is either an episode of major depressive disorder (only low periods) or bipolar disorder (periods of lows and highs).
Untreated postpartum depression can negatively affect the mother, the infant and the family. Antidepressants are the most used treatments; however, for many women these drugs are not useful, resulting in a pressing need for effective treatments for postpartum depression. Lack of sleep is common after delivery and can trigger depression in some women. Quetiapine, a drug used for bipolar disorder, major depressive disorder and occasionally sleeplessness has not been well studied in postpartum depression. This study aims to find out how mothers tolerate the drug and whether it is effective for postpartum depression. Results of this study may help investigators carry out a larger study comparing quetiapine and placebo (a sugar pill) in postpartum depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Outpatient woman between ages 18 - 45
- •Within 6 months of delivery
- •Have a DSM-5 diagnosis of MDD or BD I, BD II or other specified bipolar or related disorder with peripartum onset
- •Have a score of >18 on the 17-item Hamilton Depression Rating Scale (HDRS)
- •Have a score of ≤12 Young Mania Rating Scale (YMRS) at both the screening and baseline visits
- •Able to communicate in English
- •Capable of providing informed consent
排除标准
- •A diagnosis of schizophrenia spectrum or other psychotic disorders, obsessive-compulsive disorder, eating disorders, substance-related and addictive disorders
- •At high risk for suicide (actively suicidal or a score of ≥ 3 on item #3 on the HDRS)
- •Receiving a psychotropic drug such a mood stabilizer, an antidepressant or a sedative/hypnotic.
- •Receiving psychotherapy
- •Have a physical illness that is a contraindication to the use of quetiapine, or who have a history of intolerance or nonresponse to quetiapine
- •Pregnant or planning on becoming pregnant during the study
研究组 & 干预措施
Quetiapine
They will initially be given 25 mg of quetiapine per day. The dose may be increased by 25-50 mg per week, to a maximum dose of 150 mg per day by week 6 of the study.
干预措施: Quetiapine (Drug)
结局指标
主要结局
Recruitment and retention rate
时间窗: 10 weeks
Data on the recruitment rate, refusal rate, retention rate will be used to assess feasibility
Blood pressure
时间窗: 8 weeks
The measurement of blood pressure (both systolic and diastolic blood pressure) will be measured in mm HG
Incidence of Treatment-Emergent Adverse Events as assessed by the Systematic Monitoring of Adverse events Related to TreatmentS (SMARTS) score
时间窗: 8 weeks
The Systematic Monitoring of Adverse events Related to TreatmentS (SMARTS), will be used to gather information about side effects of quetiapine. It is a check list to identify potential side effects.
Fasting lipid panel test
时间窗: 8 weeks
The fasting lipid panel will be completed to measure safety of the intervention. This measures lipid levels (Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides). All measured in mg/dL
glycated haemoglobin (HbA1c) tests
时间窗: 8 weeks
Glycated haemoglobin (HbA1C) test will be done to measure glycated haemoglobin which will measure the safety of the intervention. It will be measured in mmol/mol and as a percentage.
Waist circumference
时间窗: 8 weeks
Waist circumference (cm) will help measure the safety of the intervention
Returned tablet count
时间窗: 8 weeks
Adherence will be determined by returned tablet count.
Maternal functioning will be measured by the Barkin Index of Maternal Functioning (BIMF)
时间窗: 8 weeks
Tolerability described as the degree to which overt adverse effects are tolerated, will be measured using the Barkin Index of Maternal Functioning (BIMF). The Barkin Index of Maternal Functioning score from baseline to week 8 will also be assessed. The sum of the scores is calculated, ranging from 0 to 120. Where a score of 120 means perfect functioning. The different between the scores scores will be looked at and a more positive score (8 week score is greater than baseline score) is a better outcome.
Pulse
时间窗: 8 weeks
Pulse will be measured in beats per minute
Body mass index
时间窗: 8 weeks
Weight (km) and height (m) will be used to calculate BMI (kg/m\^2)
次要结局
- Hamilton Depression Rating (HDRS) total score(8 weeks)
- Edinburgh Postnatal Depression Scale(8 weeks)
- Generalized Anxiety Disorder 7-item scale(8 weeks)
- Young Mania Rating Scale(8 weeks)
研究者
Verinder Sharma
Principal investigator
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's