search
Back to results

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

Primary Purpose

Major Depressive Disorder, Insomnia, Hot Flashes

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Quetiapine Extended Release
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Insomnia, Hot Flashes, Menopause, Quetiapine

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Women's Health Concerns Clinic (WHCC)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Use of quetiapine, flexible dose (150-300 mg/day) for 8 weeks, following a 2-week placebo lead-in phase

Outcomes

Primary Outcome Measures

Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2008
Last Updated
February 7, 2012
Sponsor
McMaster University
search

1. Study Identification

Unique Protocol Identification Number
NCT00723970
Brief Title
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

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Insomnia, Hot Flashes
Keywords
Major Depressive Disorder, Insomnia, Hot Flashes, Menopause, Quetiapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Use of quetiapine, flexible dose (150-300 mg/day) for 8 weeks, following a 2-week placebo lead-in phase
Intervention Type
Drug
Intervention Name(s)
Quetiapine Extended Release
Other Intervention Name(s)
Quetiapine extended-release (Seroquel XR)
Intervention Description
Quetiapine XR, 150-300 mg QHS, for 8 weeks
Primary Outcome Measure Information:
Title
Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes in Menopause-related scores, based on the Greene Climacteric Scale (GCS) and Hot Flash Related daily interference Scale (HFRDIS)
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio N Soares, MD, PhD
Organizational Affiliation
St. Joseph's Healthcare Hamilton, McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Health Concerns Clinic (WHCC)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P 3B6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23143411
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.
Results Reference
derived
PubMed Identifier
20814317
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs