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Trial record 49 of 450 for:    QUETIAPINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00723970
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : February 8, 2012
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Insomnia Hot Flashes Drug: Quetiapine Extended Release Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : June 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Changes in depressive scores (MADRS) from baseline (after a 2-week lead-in phase) to study end [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Changes in Menopause-related scores, based on the Greene Climacteric Scale (GCS) and Hot Flash Related daily interference Scale (HFRDIS) [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00723970

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: McMaster University Identifier: NCT00723970     History of Changes
Other Study ID Numbers: D1443C00008
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: July 2009
Keywords provided by McMaster University:
Major Depressive Disorder
Hot Flashes
Additional relevant MeSH terms:
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Quetiapine Fumarate
Sleep Initiation and Maintenance Disorders
Hot Flashes
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Signs and Symptoms
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs