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临床试验/NCT00723970
NCT00723970已完成4 期

Seroquel XR for the Treatment of Peri and Postmenopausal Women With Major Depressive Disorder: Impact on Mood, Physical Symptoms, Sleep and Quality of Life

McMaster University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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