A randomised double-blinded interventional trial of Estradiol and Zoloft to treat Menopausal Depressio

Phase 3

• Conditions: Menopausal depression; Depression; Menopause; Mental Health - Depression; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12624000475549
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-17
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

i.Females who are currently physically well
ii.45 – 60 years of age
iii.Current DSM-5 diagnosis of depression disorder
iv.MENO-D score > 20
v.Able to give informed consent
vi.Menopausal as determined by standardised classification guidelines for female reproductive aging (Stages of Reproductive – STRAW)
vii.First-onset or relapse of depression during menopause
viii.Evidence of a normal mammogram in the preceding 24 months
ix.Documented normal Pap smear and pelvic examination in the preceding two years
x.English language proficiency (to provide informed consent and complete cognitive test battery)

Exclusion Criteria

i.Patients with known abnormalities in the hypothalamic-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.
ii.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.
iii.Patients experiencing severe melancholia, neurovegetative symptoms or current suicidality necessitating acute hospitalisation or intensive psychiatric treatment.
iv.Patients whose depressive illness is directly related to illicit substance use
v.Patients with psychotic symptoms or past history of severe mental illness including schizophrenia, and bipolar disorder.
vi.Pregnancy / Lactation
vii.Smoking > 10 cigarettes per day, >3 standard drinks of alcohol per day, illicit drug use.
viii.Planned changes to psychotropic medication or psychotherapy regimen.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Menopausal depression[Montgomery-Asberg Depression Rating Scale Baseline and Week 12 post-commencement of intervention];Menopausal depression[MENO-D Baseline and Week 12 post-commencement of intervention]

Secondary Outcome Measures

Name	Time	Method
Menopausal depression[Cognitive assessments including Cogstate and Everyday Memory Questionnaire – Revised will be assessed together as a composite secondary outcome Baseline vs Week 12 post-commencement of intervention];Menopausal depression[Neutral and Emotional eye tracking task Baseline vs Week 12 post-commencement of intervention]