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

Information source: McMaster University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder; Insomnia; Hot Flashes

Intervention: Quetiapine Extended Release (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: McMaster University

Official(s) and/or principal investigator(s):
Claudio N Soares, MD, PhD, Principal Investigator, Affiliation: St. Joseph's Healthcare Hamilton, McMaster University

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end

Secondary outcome: Changes in Menopause-related scores, based on the Greene Climacteric Scale (GCS) and Hot Flash Related daily interference Scale (HFRDIS)

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).

Eligibility

Minimum age: 40 Years. Maximum age: 60 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- women 40 to 60 years

- diagnosis of MDD

- perimenopausal or postmenopausal

Exclusion Criteria:

- using HRT

- using psychotropic medications

- other DSM-IV axis I diagnoses other than MDD

Locations and Contacts

Women's Health Concerns Clinic (WHCC), Hamilton, Ontario L8P 3B6, Canada
Additional Information

Starting date: June 2007
Last updated: February 7, 2012

Page last updated: August 23, 2015

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