Improving cognitive function in postmenopausal women with depression using estrogen

Beijing Anding Hospital Affiliated to Capital Medical University

This study is testing if a combination of estrogen therapy and antidepressants can help improve thinking skills and reduce depression in postmenopausal women.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: N/A to 70 Years
• Sex: Female
• Sponsor: Capital Medical University (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06358014 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of estrogen therapy on cognitive levels in women suffering from postmenopausal depression. It aims to assess whether the combination of estradiol and norethindrone acetate, along with SSRIs, can enhance cognitive function and alleviate depressive symptoms. The study targets women who have experienced natural menopause for at least one year and meet specific diagnostic criteria for major depressive disorder. Participants will be evaluated based on their cognitive impairment and depression severity using standardized scales.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women aged 70 or younger with first-onset major depressive disorder and cognitive impairment.

Not a fit: Patients with significant physical illnesses or other psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve cognitive function and reduce depressive symptoms in postmenopausal women.

How similar studies have performed: Other studies have shown promising results with estrogen therapy in improving cognitive function in similar populations, suggesting a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Female patients from outpatient or inpatient departments;
2. Patients who sign a written informed consent form;
3. Natural menopause for at least 1 year, with first-onset depression, aged ≤70 years;
4. Meeting the diagnostic criteria for Major Depressive Disorder according to the Diagnostic and Statistical Manual of Mental Disorders-fifth Edition (DSM-5);
5. HAMD-17 score ≥17 points;
6. Presence of cognitive impairment symptoms, Montreal Cognitive Assessment scale (MoCA) \<26 points;
7. Education level of primary school or above.

Exclusion Criteria:

1. Patients with significant physical illness, cranial trauma, or other serious unstable physical illnesses;
2. Patients who have participated in another interventional clinical study in the past month;
3. History or current diagnosis of the following psychiatric disorders according to DSM-5: organic mental disorders, Alzheimer's disease, other causes of secondary dementia, schizophrenia, schizoaffective disorder, bipolar affective disorder, delusional disorder, unspecified mental disorders, patients with a history of substance abuse, including alcohol and active substance abuse in the past 12 months, excluding nicotine;
4. Currently taking antidepressants, cognitive enhancers, or other psychiatric medications in the past 2 weeks;
5. Severe speech, visual, or hearing impairments that prevent completion of scale assessments;
6. Individuals with severe suicidal ideation or suicidal behavior;
7. Patients with malignant tumors;
8. Known or suspected history of breast cancer;
9. Known or suspected estrogen-dependent malignant tumors (such as endometrial cancer);
10. Known or suspected progesterone-dependent tumors;
11. Untreated endometrial hyperplasia;
12. Unexplained vaginal bleeding.

Where this trial is running

Beijing

• Beijing Anding Hospital Affiliated to Capital Medical University — Beijing, China (RECRUITING)

Conditions: Postmenopausal Depression, Estrogen