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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Use of quetiapine, flexible dose (150-300 mg/day) for 8 weeks, following a 2-week placebo lead-in phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine Extended Release | Drug | Quetiapine XR, 150-300 mg QHS, for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Menopause-related scores, based on the Greene Climacteric Scale (GCS) and Hot Flash Related daily interference Scale (HFRDIS) | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio N Soares, MD, PhD | St. Joseph's Healthcare Hamilton, McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Health Concerns Clinic (WHCC) | Hamilton | Ontario | L8P 3B6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23143411 | Derived | 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. | |
| 20814317 | Derived | Soares 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. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |