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Completed

NCT Number: NCT00723970

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Dyssomnias Hot Flashes Insomnia Mental Disorders Mood Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Women's Health Concerns Clinic (WHCC)

Hamilton, Ontario, L8P 3B6, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine Extended Release

Drug

Quetiapine XR, 150-300 mg QHS, for 8 weeks

Other names: Quetiapine extended-release (Seroquel XR)

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 29, 2008
Registry last updated
Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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