Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358014
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-01
Brief Title:
Assessment of the Improvement in Cognitive Levels of Postmenopausal Depression Patients by Estrogen
Sponsor:
Xiao Wang
Organization:
Capital Medical University
Study Overview
Official Title:
Beijing Anding Hospital Affiliated to Capital Medical University
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 attentionThis 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None