Quetiapine XR for the Treatment of Menopausal Depression
Information source: McMaster University
Information obtained from ClinicalTrials.gov on November 03, 2008
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: Recruiting
Sponsored by: Hamilton Health Sciences Official(s) and/or principal investigator(s):
Claudio N Soares, MD, PhD, Principal Investigator, Affiliation: St. Joseph's Healthcare Hamilton, McMaster University
Overall contact:
Claudio N Soares, MD, PhD, Phone: 905-5221155, Ext: 32059, Email: csoares@mcmaster.ca
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, we 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: Treatment, Non-Randomized, Single Blind (Subject), Uncontrolled, Single Group Assignment, Efficacy Study
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 the 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
Claudio N Soares, MD, PhD, Phone: 905-5221155, Ext: 32059, Email: csoares@mcmaster.ca
Women's Health Concerns Clinic (WHCC), Hamilton, Ontario L8P 3B6, Canada; Recruiting
Claudio Soares, MD, PhD, Email: csoares@mcmaster.ca
Claudio Soares, MD, PhD, Principal Investigator
Additional Information
Starting date: June 2007
Ending date: December 2008
Last updated: July 25, 2008
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