Postmenopausal DepressionNCT06358014
Assessment of the Improvement in Cognitive Levels of Postmenopausal Depression Patients by Estrogen
A study testing Fematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIs and SSRIs in people with Postmenopausal Depression and Estrogen, run by Xiao Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 70 years, women only
- Conditions the study is for
- Postmenopausal Depression, Estrogen
- What is being tested?
- Fematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIs and SSRIs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female patients from outpatient or inpatient departments;
- Patients who sign a written informed consent form;
- Natural menopause for at least 1 year, with first-onset depression, aged ≤70 years;
- Meeting the diagnostic criteria for Major Depressive Disorder according to the Diagnostic and Statistical Manual of Mental Disorders-fifth Edition (DSM-5);
- HAMD-17 score ≥17 points;
- Presence of cognitive impairment symptoms, Montreal Cognitive Assessment scale (MoCA) <26 points;
- Education level of primary school or above.
Who cannot join
- Patients with significant physical illness, cranial trauma, or other serious unstable physical illnesses;
- Patients who have participated in another interventional clinical study in the past month;
- 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;
- Currently taking antidepressants, cognitive enhancers, or other psychiatric medications in the past 2 weeks;
- Severe speech, visual, or hearing impairments that prevent completion of scale assessments;
- Individuals with severe suicidal ideation or suicidal behavior;
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- Patients with malignant tumors;
- Known or suspected history of breast cancer;
- Known or suspected estrogen-dependent malignant tumors (such as endometrial cancer);
- Known or suspected progesterone-dependent tumors;
- Untreated endometrial hyperplasia;
- Unexplained vaginal bleeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing
xiao wang, prof, +8658303103, wangxiaofight2016@163.com
About this study
Official title: Beijing Anding Hospital Affiliated to Capital Medical University
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
- Being tested
- Fematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIs, SSRIs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIsDrug
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.
SSRIsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| The combination group is estrogen combined with SSRIs for 8 weeks | Experimental | The estradiol/estradiol-norethindrone acetate combination tablet will be taken orally before bedtime, 1 tablet/d (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, with no specific restrictions on the type of drugs. Receives: Drug: Fematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIs |
| SSRIs for 8 weeks | Placebo comparator | This study uses SSRIs class drugs, including fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, and escitalopram, with no specific restrictions on the type of drugs. Receives: Drug: SSRIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average change value of MOCA total scores from baseline to 8 weeks of treatment, as assessed by raters, is the primary efficacy endpoint(0-8week).
Montreal Cognitive Assessment (MoCA) Test is based on scores with a maximum score of 30. It takes 10 to 12 minutes to complete.The cutoff for a normal MoCA score is 26. Scores of 25 and below may indicate mild cognitive impairment.
Measured: 8 week
Secondary outcomes (5)
The average change value of HAMD-17 total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures
Hamilton Depression Rating Scale (HAMD-17) is scored by summing the item scores. The total score can range from 0 to 54, with higher scores indicating a greater severity of depression. 0 - 7 = Normal. 8 - 13 = Mild Depression. 14-18 = Moderate Depression. 19 - 22 = Severe Depression. > 23 = Very Severe Depression
Measured: 8 week
The average change value of HAMA total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures
Hamilton Anxiety Rating Scale (HAMA) ,Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indi- cates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: 8 week
The average change value of Kupperman total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures
The Blatt-Kupperman menopausal index included 11 symptoms which were rated on a four point scale from 0=none to 3=severe. These ratings were then summed across the 11 items and the score was categorized as follows: none 0-5, mild 5-10, moderate 10-15, severe 15+.
Measured: 8 week
The average change value of PSQI total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures
Pittsburgh Sleep Quality Index (PSQI) Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Measured: 8 week
The average change value of ADL total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures
Activities of Daily Living (ADL) scores of 0-20 indicate "total" dependency scores of 21-60 indicate "severe" dependency scores of 61-90 indicate "moderate" dependency scores of 91-99 indicate "slight" dependency most studies use a score of 60/61 (moderate dependency) as a cutting point
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start12 May 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The combination group will receive estrogen combined with Selective serotonin reuptake inhibitors (SSRIs) , while the control group will only receive Selective serotonin reuptake inhibitors (SSRIs) intervention.SSRIs include Citalopram (Celexa) , Escitalopram (Lexapro) ,Fluoxetine (Prozac) ,Paroxetine (Paxil, Pexeva) and Sertraline (Zoloft)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiao Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao Wang, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358014
- Sponsor's protocol ID
- YX2021-02
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "We currently have no plans to provide Individual Participant Data (IPD) to other researchers."
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing Anding Hospital Affiliated to Capital Medical University
- ClinicalTrials.gov ID
- NCT06358014
- Acronym / sponsor ID
- YX2021-02
- Conditions
- Postmenopausal Depression, Estrogen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xiao WangUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The combination group will receive estrogen combined with Selective serotonin reuptake inhibitors (SSRIs) , while the control group will only receive Selective serotonin reuptake inhibitors (SSRIs) intervention.SSRIs include Citalopram (Celexa) , Escitalopram (Lexapro) ,Fluoxetine (Prozac) ,Paroxetine (Paxil, Pexeva) and Sertraline (Zoloft)
| Arm | Type | Receives |
|---|---|---|
| The combination group is estrogen combined with SSRIs for 8 weeks | Experimental | Drug: Fematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIsThe estradiol/estradiol-norethindrone acetate combination tablet will be taken orally before bedtime, 1 tablet/d (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, with no specific restrictions on the type of drugs. |
| SSRIs for 8 weeks | Placebo comparator | Drug: SSRIsThis study uses SSRIs class drugs, including fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, and escitalopram, with no specific restrictions on the type of drugs. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients from outpatient or inpatient departments;
- Patients who sign a written informed consent form;
- Natural menopause for at least 1 year, with first-onset depression, aged ≤70 years;
- Meeting the diagnostic criteria for Major Depressive Disorder according to the Diagnostic and Statistical Manual of Mental Disorders-fifth Edition (DSM-5);
- HAMD-17 score ≥17 points;
Key exclusion criteria (12 listed)
- Patients with significant physical illness, cranial trauma, or other serious unstable physical illnesses;
- Patients who have participated in another interventional clinical study in the past month;
- 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;
- Currently taking antidepressants, cognitive enhancers, or other psychiatric medications in the past 2 weeks;
- Severe speech, visual, or hearing impairments that prevent completion of scale assessments;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIsIn 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 | The combination group is estrogen combined with SSRIs for 8 weeks |
| SSRIsThis 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. | Drug | SSRIs for 8 weeks |
Primary outcome
The average change value of MOCA total scores from baseline to 8 weeks of treatment, as assessed by raters, is the primary efficacy endpoint(0-8week).
Time frame: 8 week
Montreal Cognitive Assessment (MoCA) Test is based on scores with a maximum score of 30. It takes 10 to 12 minutes to complete.The cutoff for a normal MoCA score is 26. Scores of 25 and below may indicate mild cognitive impairment.
5 secondary outcomes
The average change value of HAMD-17 total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures
Time frame: 8 week
The average change value of HAMA total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures
Time frame: 8 week
The average change value of Kupperman total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures
Time frame: 8 week
The average change value of PSQI total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures
Time frame: 8 week
The average change value of ADL total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No. "We currently have no plans to provide Individual Participant Data (IPD) to other researchers."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIs and SSRIs in people with Postmenopausal Depression and Estrogen, run by Xiao Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average change value of MOCA total scores from baseline to 8 weeks of treatment, as assessed by raters, is the primary efficacy endpoint(0-8week). (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.