Seroquel XR for the Treatment of Peri and Postmenopausal Women With Major Depressive Disorder: Impact on Mood, Physical Symptoms, Sleep and Quality of Life
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end
研究概览
简要总结
The study was designed to examine the efficacy and tolerability of quetiapine XR for the treatment of women who suffer from depression in the context of the menopausal transition and postmenopausal years. Besides the improvement of depressive symptoms, the investigators are interested in examining the impact of this medication on vasomotor symptoms (hot flashes, night sweats), sleep and overall quality of life.
详细描述
The menopause transition (or perimenopause) and the early postmenopausal years are marked by intense hormone fluctuations; hormone changes are frequently accompanied by the occurrence hot flashes, night sweats and sleep disturbance. Recent epidemiologic studies also demonstrate that perimenopause is a period of greater risk for the development of depressive symptoms.
To date, serotonergic antidepressants such as paroxetine and escitalopram have shown to be efficacious for the treatment of women with depression and menopause-related symptoms. We hypothesize that the use of quetiapine for this sub-population will alleviate symptoms of depression; we also anticipate that its use may enhance quality of life and improve vasomotor symptoms - the latter possibly due to quetiapine's effect on 5HT receptors and/or due to its sleep-promoting properties (e.g., by increasing the duration of total sleep time [TST], enhancing sleep efficiency, and decreasing the number of awakenings due to hot flashes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women 40 to 60 years
- •diagnosis of MDD
- •perimenopausal or postmenopausal
排除标准
- •using HRT
- •using psychotropic medications
- •other DSM-IV axis I diagnoses other than MDD
研究组 & 干预措施
A
Use of quetiapine, flexible dose (150-300 mg/day) for 8 weeks, following a 2-week placebo lead-in phase
干预措施: Quetiapine Extended Release (Drug)
结局指标
主要结局
Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end
时间窗: 8 weeks
次要结局
- Changes in Menopause-related scores, based on the Greene Climacteric Scale (GCS) and Hot Flash Related daily interference Scale (HFRDIS)(8 weeks)
