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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00723970
Enrollment
40
Registered
2008-07-29
Start date
2007-06-30
Completion date
2009-05-31
Last updated
2012-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes, Insomnia, Major Depressive Disorder

Keywords

Major Depressive Disorder, Insomnia, Hot Flashes, Menopause, Quetiapine

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).

Interventions

Quetiapine XR, 150-300 mg QHS, for 8 weeks

Sponsors

McMaster University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end8 weeks

Secondary

MeasureTime frame
Changes in Menopause-related scores, based on the Greene Climacteric Scale (GCS) and Hot Flash Related daily interference Scale (HFRDIS)8 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026