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

McMaster University

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder; Insomnia; Hot Flashes

Treatments: Drug: Quetiapine Extended Release

Study type: Interventional

Funder types: Other

Identifiers

NCT00723970

D1443C00008

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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40 participants in 1 patient group

A

Experimental group

Description:

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

Treatment:

Drug: Quetiapine Extended Release