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ER Beta Agonist
ER Beta Agonist for Depression
Phase 2
Waitlist Available
Led By Peter J Schmidt, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women aged 45 to 65
Subjects must have consent capacity
Must not have
Current Axis 1 psychiatric illness or clinically significant sleep disorder
History of ischemic cardiac disease, pulmonary embolism, or thrombophlebitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing
Summary
This trial is testing the safety and efficacy of a drug to treat depression in women who have previously responded to estrogen therapy.
Who is the study for?
This trial is for healthy women aged 45-65 who experienced depression during perimenopause, which improved with estradiol therapy. They must not be on any medication except possibly thyroid replacements or occasional NSAIDs/allergy meds, and use barrier birth control if able to get pregnant.
What is being tested?
The study tests LY500307, an ER beta agonist, against a placebo in women whose mood symptoms may return after stopping estrogen therapy. It involves initial estrogen treatment followed by either the test drug or placebo and includes blood tests, psychiatric interviews, ultrasounds, and symptom logging.
What are the potential side effects?
While specific side effects of LY500307 are not listed here, participants will be monitored for mood changes and other potential reactions through blood samples, vital signs checks, and questions about their well-being.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged between 45 and 65.
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I am capable of understanding and consenting to participate.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a major psychiatric illness or serious sleep disorder.
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I have had heart disease, blood clots in my lungs, or vein inflammation.
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I have kidney, liver issues, gallbladder inflammation, or high blood pressure.
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I have had breast cancer or an unexamined breast lump.
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I have a history of uterine cancer or unexplained issues in my pelvic area.
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I am not pregnant and will use barrier methods of contraception if sexually active.
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I have felt unhappy or uncomfortable due to hormone replacement therapy.
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I have had a stroke.
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I have had major depression with thoughts of suicide in the past.
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I frequently experience migraine headaches.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ongoing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Epidemiologic Studies-Depression Scale (CES-D)
bserver ratings - the 17-item Hamilton Rating Scale of Depression (HRSD)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Arm 1Experimental Treatment1 Intervention
LY500307 at 25mg per day
Group II: Arm 2Active Control1 Intervention
LY500307 at 75mg per day
Group III: Arm 3Placebo Group1 Intervention
Matched placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ER beta agonist
2019
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)Lead Sponsor
2,936 Previous Clinical Trials
2,751,573 Total Patients Enrolled
Peter J Schmidt, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
13 Previous Clinical Trials
3,840 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a major psychiatric illness or serious sleep disorder.I have had heart disease, blood clots in my lungs, or vein inflammation.I am not on medication, except possibly for menopause, thyroid issues, occasional pain, or allergies.I have kidney, liver issues, gallbladder inflammation, or high blood pressure.I have had breast cancer or an unexamined breast lump.I have a history of uterine cancer or unexplained issues in my pelvic area.I am not pregnant and will use barrier methods of contraception if sexually active.I have felt unhappy or uncomfortable due to hormone replacement therapy.I have had a stroke.I had depression linked to perimenopause in the last 12 years, which improved with hormone therapy.I am a woman aged between 45 and 65.I have had major depression with thoughts of suicide in the past.I am capable of understanding and consenting to participate.I frequently experience migraine headaches.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 3
- Group 3: Arm 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.