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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 major-depressive-disorder
Started Jun 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFebruary 8, 2012
July 1, 2009
1.9 years
July 25, 2008
February 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end
8 weeks
Secondary Outcomes (1)
Changes in Menopause-related scores, based on the Greene Climacteric Scale (GCS) and Hot Flash Related daily interference Scale (HFRDIS)
8 weeks
Study Arms (1)
A
EXPERIMENTALUse of quetiapine, flexible dose (150-300 mg/day) for 8 weeks, following a 2-week placebo lead-in phase
Interventions
Quetiapine XR, 150-300 mg QHS, for 8 weeks
Eligibility Criteria
You may qualify if:
- women 40 to 60 years
- diagnosis of MDD
- perimenopausal or postmenopausal
You may not qualify if:
- using HRT
- using psychotropic medications
- other DSM-IV axis I diagnoses other than MDD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's Health Concerns Clinic (WHCC)
Hamilton, Ontario, L8P 3B6, Canada
Related Publications (2)
Frey BN, Haber E, Mendes GC, Steiner M, Soares CN. Effects of quetiapine extended release on sleep and quality of life in midlife women with major depressive disorder. Arch Womens Ment Health. 2013 Feb;16(1):83-5. doi: 10.1007/s00737-012-0314-y. Epub 2012 Nov 11.
PMID: 23143411DERIVEDSoares CN, Frey BN, Haber E, Steiner M. A pilot, 8-week, placebo lead-in trial of quetiapine extended release for depression in midlife women: impact on mood and menopause-related symptoms. J Clin Psychopharmacol. 2010 Oct;30(5):612-5. doi: 10.1097/JCP.0b013e3181f1d0f2.
PMID: 20814317DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudio N Soares, MD, PhD
St. Joseph's Healthcare Hamilton, McMaster University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 29, 2008
Study Start
June 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
February 8, 2012
Record last verified: 2009-07