Clinical trial NCT00723970: Quetiapine Extended Release (XR) for the Treatment of Menopausal Depression
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Insomnia
Hot Flashes
Keywords: Major Depressive Disorder
Insomnia
Hot Flashes
Menopause
Quetiapine
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in Menopause-related scores, based on the Greene Climacteric Scale (GCS) and Hot Flash Related daily interference Scale (HFRDIS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Women's Health Concerns Clinic (WHCC)
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton, McMaster University
name: Claudio N Soares, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.