RecruitingPhase 2ACTRN12620001015932

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

Sponsor

Monash University

Enrollment

90 participants

Start Date

Dec 15, 2020

Study Type

Interventional

Conditions

Menopause Depression

Summary

The purpose of this study is to investigate the use of the medication combination Bazedoxifene and conjugated estrogen, a hormone replacement therapy, in the treatment of depression with a first onset or relapse during the peri-menopausal phase that is still persisting. The study will employ a 12-week, double-blind, randomised, two-arm parallel-group design. Participants will be randomised to one of two groups: (1) Daily oral Bazedoxifene and conjugated estrogen (20mg/0.30mg), (2) Placebo (sugar pill). The aim is to compare, in a twelve-week double-blind randomised controlled trial, the psychological and physical outcomes of women experiencing a first-onset, relapse or persistent depressive symptoms that commenced during the peri-menopause in four groups: i) women taking Bazedoxifene and conjugated estrogen (20mg/0.30mg oral/day) in adjunct to standard antidepressant treatment, ii) women taking placebo in adjunct to standard antidepressant treatment, iii) women taking Bazedoxifene and conjugated estrogen (20mg/0.30mg oral/day), iv) women taking placebo alone (i.e. women not using any psychotropic / hormone treatment). It is hypothesized that women receiving Bazedoxifene plus conjugated estrogen alone, and Bazedoxifene plus conjugated estrogen in adjunct to standard antidepressant medication will have the same as or significantly greater improvement in depressive symptoms compared with women receiving placebo in adjunct to standard SSRI and women not using any psychotropic/hormone treatment.

Eligibility

Sex: FemalesMin Age: 40 YearssMax Age: 65 Yearss

Inclusion Criteria9

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 Criteria10

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.

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Interventions

To compare, in a twelve-week double-blind randomised controlled trial, the psychological and physical outcomes of women experiencing a first-onset, relapse or persistent depressive symptoms that commenced during the peri-menopause in four groups: i) women taking Bazedoxifene and conjugated estrogen (20mg/0.30mg oral/day) in adjunct to standard antidepressant treatment, ii) women taking placebo in adjunct to standard antidepressant treatment, iii) women taking Bazedoxifene and conjugated estrogen (20mg/0.30mg oral/day), iv) women taking placebo alone (i.e. women not using any psychotropic / hormone treatment). 20mg Bazedoxifene (Conbriza) / 0.30 mg Conjugated Estrogen (Premarin) Dose: 0.30 mg Conjugated Estrogen and 20mg Bazedoxifene daily for 12 weeks. Duration: 12 weeks. Mode: Modified release Tablet Adherence: Medication adherence will be assessed fortnightly. Empty bottles will be collected by the study coordinator and questions include detailing any missed tablets, and questioning how many bottles/pills are leftover - responses are recorded.