RecruitingNot ApplicableNCT06358014

Assessment of the Improvement in Cognitive Levels of Postmenopausal Depression Patients by Estrogen

Beijing Anding Hospital Affiliated to Capital Medical University


Sponsor

Xiao Wang

Enrollment

40 participants

Start Date

May 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

After menopause, there is a certain tendency towards depression, with the risk of developing depression being about 3 to 4 times higher than before menopause. Additionally, postmenopausal women experience varying degrees of cognitive decline, which are closely associated with hormonal changes. Therefore, we should pay more attention to the cognitive levels of postmenopausal depression patients. Increasing evidence suggests that changes in cognitive function during menopause may be related to the effects of estrogen on cognitive function, and estrogen therapy can effectively improve cognitive decline. Estrogen is not only associated with cognitive symptoms after menopause, but estrogen intervention is also an adjunctive treatment for postmenopausal depression symptoms. There is a close relationship between cognitive levels and depression, as depression itself is accompanied by cognitive decline, and early cognitive decline can also manifest depressive symptoms. Therefore, the cognitive levels of postmenopausal depression patients are also worthy of further attention.This study is an 8-week randomized controlled trial. The subjects are patients with postmenopausal depression accompanied by cognitive decline, all of whom have undergone natural menopause for at least one year; with HAMD-17 scores ≥17 points; and MOCA scores ≤26 points. This study aims to recruit patients with postmenopausal depression accompanied by cognitive decline from the outpatient or inpatient departments of Beijing Anding Hospital, Capital Medical University. Patients who meet the inclusion criteria will be randomly assigned to the combination group and the control group using a random number method. The combination group will receive estrogen combined with SSRIs, while the control group will only receive Selective serotonin reuptake inhibitors (SSRIs) intervention. Patients' cognitive function and depressive symptoms will be assessed using scales at baseline, 2 weeks, 4 weeks, and the end of 8 weeks of treatment, and safety evaluations will be conducted. The primary efficacy endpoint is the change in MoCA scores from baseline to the end of the study. Secondary efficacy endpoints include changes in HAMD-17, modified Kupperman Scale, ADL Scale, and hormone levels from baseline to the end of the study. The safety of the study drug will be evaluated through adverse event reporting, clinical laboratory tests, and physical examinations.


Eligibility

Sex: FEMALEMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether estrogen therapy can improve memory and thinking abilities in women who have gone through menopause and are experiencing depression-related cognitive problems. Menopause-related drops in estrogen may affect the brain, and this study wants to see if supplementing estrogen helps. **You may be eligible if...** - You are a woman aged 70 or under who has been through natural menopause for at least 1 year - You have been newly diagnosed with major depressive disorder (first episode) - You have a depression score of 17 or higher on a standard scale (HAMD-17) - You show signs of cognitive difficulty (score below 26 on the MoCA test) - You completed at least primary school education **You may NOT be eligible if...** - You have serious physical illness, brain injury, or unstable medical conditions - You have participated in another interventional clinical study in the past month - You have a history of bipolar disorder, schizophrenia, or other serious psychiatric conditions - You have previously had depression or this is not your first episode Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIs

In the combination group, eligible subjects will receive 1 tablet/day of estradiol/estradiol-norethindrone acetate combination tablet for 8 weeks. The estradiol/estradiol-norethindrone acetate combination tablet will be taken orally before bedtime, 1 tablet/day (trade name: Fematon, Abbott Laboratories, USA, this product is a combination package, with estradiol 1 mg in the first 14 days of each treatment cycle, and estradiol 1 mg and norethindrone acetate 10 mg in the last 14 days of each treatment cycle). This study uses SSRIs class drugs, including fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, and escitalopram.

DRUGSSRIs

This study uses SSRIs class drugs, including fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, and escitalopram, with no specific restrictions on the type of drugs. During the study, medication doses will be quantitatively adjusted based on the results of each visit assessment combined with drug concentrations.


Locations(1)

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06358014


Related Trials