A randomised double-blinded interventional trial of the efficacy of Estradiol and Zoloft in treating Menopausal Depression

Monash University0 个研究点目标入组 120 人开始时间: 2024年4月17日最近更新: 2024年4月22日

适应症

试验速览

暂无简介。

•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)

•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.

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