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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00723970
Other study ID # D1443C00008
Secondary ID
Status Completed
Phase Phase 4
First received July 25, 2008
Last updated February 7, 2012
Start date June 2007
Est. completion date May 2009

Study information

Verified date July 2009
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaCanada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 60 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Drug:
Quetiapine Extended Release
Quetiapine XR, 150-300 mg QHS, for 8 weeks

Locations

Country Name City State
Canada Women's Health Concerns Clinic (WHCC) Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end 8 weeks No
Secondary Changes in Menopause-related scores, based on the Greene Climacteric Scale (GCS) and Hot Flash Related daily interference Scale (HFRDIS) 8 weeks No
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