NCT00723970

Quetiapine Extended Release (XR) for the Treatment of Menopausal Depression

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Major Depressive Disorder
• Insomnia
• Hot Flashes

Interventions

Type	Name	Description
DRUG	Quetiapine Extended Release	Quetiapine XR, 150-300 mg QHS, for 8 weeks

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-07-29
• Last updated: 2012-02-08

Locations

1 site across 1 country: Canada