Quetiapine Extended Release (XR) for the Treatment of Menopausal Depression - Full Text View

Sponsor:	McMaster University
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00723970

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Subject), Uncontrolled, Single Group Assignment, Efficacy Study
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:

MedlinePlus related topics: Depression Menopause

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

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
A: Experimental 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

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

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

Responsible Party:	St. Joseph's Healthcare Hamilton ( Claudio Soares MD, PhD, FRCPC )
Study ID Numbers:	D1443C00008
Study First Received:	July 25, 2008
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00723970 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

Major Depressive Disorder
Insomnia
Hot Flashes
Menopause
Quetiapine

Additional relevant MeSH terms:

Depression
Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Hot Flashes
Central Nervous System Depressants
Depressive Disorder, Major
Depressive Disorder
Antipsychotic Agents

Pharmacologic Actions
Behavioral Symptoms
Signs and Symptoms
Quetiapine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 04, 2010