NCT06358014

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

Beijing Anding Hospital Affiliated to Capital Medical University

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xiao Wang · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postmenopausal Depression
• Estrogen

Interventions

Type	Name	Description
DRUG	Fematon (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.
DRUG	SSRIs	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.

Timeline

• Start date: 2023-05-12
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2024-04-10
• Last updated: 2024-04-10

Locations

1 site across 1 country: China