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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT00723970
First received: July 25, 2008
Last updated: February 7, 2012
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Insomnia
Hot Flashes
Drug: Quetiapine Extended Release
Phase 4

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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Menopause-related scores, based on the Greene Climacteric Scale (GCS) and Hot Flash Related daily interference Scale (HFRDIS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Use of quetiapine, flexible dose (150-300 mg/day) for 8 weeks, following a 2-week placebo lead-in phase
Drug: Quetiapine Extended Release
Quetiapine XR, 150-300 mg QHS, for 8 weeks
Other Name: Quetiapine extended-release (Seroquel XR)

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

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723970

Locations
Canada, Ontario
Women's Health Concerns Clinic (WHCC)
Hamilton, Ontario, Canada, L8P 3B6
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Claudio N Soares, MD, PhD St. Joseph's Healthcare Hamilton, McMaster University
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT00723970     History of Changes
Other Study ID Numbers: D1443C00008
Study First Received: July 25, 2008
Last Updated: February 7, 2012
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by McMaster University:
Major Depressive Disorder
Insomnia
Hot Flashes
Menopause
Quetiapine

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Hot Flashes
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Signs and Symptoms
Pathologic Processes
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 19, 2014