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

NCT ID: NCT00723970

Last Updated: 2012-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-05-31

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).

Conditions

Major Depressive Disorder; Insomnia; Hot Flashes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

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

Group Type: EXPERIMENTAL

Quetiapine Extended Release

Intervention Type: DRUG

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

Interventions

Quetiapine Extended Release

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

Intervention Type: DRUG

Other Intervention Names

Quetiapine extended-release (Seroquel XR)

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio N Soares, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Healthcare Hamilton, McMaster University

Locations

Women's Health Concerns Clinic (WHCC)

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 23143411 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20814317 (View on PubMed)

Other Identifiers

D1443C00008

Identifier Type: -

Identifier Source: org_study_id