None listed
Conditions
Brief summary
Depressive symptoms are prevalent among middle-aged women, especially during the menopausal transition. However, the impact of menopause on depression is often overlooked, leading to inadequate treatment and poor outcomes. While current guidelines recommend traditional antidepressants as first-line management, the evidence for hormonal therapy is limited. To address this gap, we propose a new clinical trial comparing the efficacy of Menopause Hormone Therapy and antidepressants in treating menopausal depression. Given that menopausal depression most likely stems from hormonal fluctuations, it is hypothesised that hormonal treatments are more appropriate than antidepressants.
Interventions
50mcg estradiol transdermal patch applied twice a week and 100mg prometrium oral tablet taken daily (both for 12 weeks in total)
Adherence will be assessed at each visit with participant reporting number of pills left
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 60 Years
Healthy volunteers
No
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.
Outcome results
None listed