Double-Blind Randomised Investigation of Bazedoxifene and Conjugated Estrogen for Depression in Menopausal Wome

Phase 2

Recruiting

• Conditions: Depression; Menopause; Mental Health - Depression

• Registration Number: ACTRN12620001015932
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-07
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Females who are currently physically well

Current DSM-IV diagnosis of depression disorder

Able to give informed consent

Menopausal as determined by standardized classification guidelines for female reproductive ageing were proposed at the Stages of Reproductive (STRAW).

First-onset or relapse of depression during menopause

Currently taking either an SSRI or SNRI, or no psychotropic medication at all

Evidence of a normal mammogram in the preceding 24 months.

Documented normal Pap smear and pelvic examination in the preceding two years.

English language proficiency (in order to provide informed consent and complete cognitive test battery)

Exclusion Criteria

•Patients with known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event, breast pathology, undiagnosed vaginal bleeding or abnormal Pap smear results.
•Patients with any significant unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; or the presence of illness causing immobilisation.
•Patients experiencing severe melancholia, neurovegetative symptoms or current suicidality necessitating acute hospitalisation or intensive psychiatric treatment.
•Patients whose psychotic illness is directly related to illicit substance use or who have a history of substance dependence during the last six months (with the exclusion of caffeine and/or nicotine dependence).
•Patients with psychotic symptoms or past history of severe mental illness including schizophrenia, and bipolar disorder.
•Women aged 40 or over who have not had a normal mammogram in the last 24 months
•Current use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including Bazedoxifene or use of phytoestrogen supplements as powder or tablet
•Pregnancy / Lactation
•Smoking cigarettes, >4 standard drinks of ETOH per day, illicit drug dependence.
•Planned changes to psychotropic medication or psychotherapy regimen.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MONTGOMERY-ASBERG DEPRESSION RATING SCALE (MADRS)<br><br>[ Mean change from Baseline to Week 12 after intervention commencement ]