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

Phase 4

Completed

• Conditions: Major Depressive Disorder; Insomnia; Hot Flashes
• Interventions: Drug: Quetiapine Extended Release

• Registration Number: NCT00723970
• Lead Sponsor: McMaster University

Brief 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).

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-07
• Last Update Submitted: 2012-02-07
• Last Update Posted: 2012-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• women 40 to 60 years
• diagnosis of MDD
• perimenopausal or postmenopausal

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Exclusion Criteria

• using HRT
• using psychotropic medications
• other DSM-IV axis I diagnoses other than MDD

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Quetiapine Extended Release	Use of quetiapine, flexible dose (150-300 mg/day) for 8 weeks, following a 2-week placebo lead-in phase

Primary Outcome Measures

Name	Time	Method
Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end	8 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in Menopause-related scores, based on the Greene Climacteric Scale (GCS) and Hot Flash Related daily interference Scale (HFRDIS)	8 weeks

Trial Locations

Locations (1)

Women's Health Concerns Clinic (WHCC); 🇨🇦 Hamilton, Ontario, Canada