Quetiapine Extended Release (XR) for the Treatment of Menopausal Depression

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723970
• Other study ID #: D1443C00008
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Hot Flashes
• Insomnia
• Major Depressive Disorder

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