← Back to Search

ER Beta Agonist

ER Beta Agonist for Depression

Phase 2

Recruiting

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

Awards & highlights

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 below

Select...

I am a woman aged between 45 and 65.

Select...

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.

Select...

I have had heart disease, blood clots in my lungs, or vein inflammation.

Select...

I have kidney, liver issues, gallbladder inflammation, or high blood pressure.

Select...

I have had breast cancer or an unexamined breast lump.

Select...

I have a history of uterine cancer or unexplained issues in my pelvic area.

Select...

I am not pregnant and will use barrier methods of contraception if sexually active.

Select...

I have felt unhappy or uncomfortable due to hormone replacement therapy.

Select...

I have had a stroke.

Select...

I have had major depression with thoughts of suicide in the past.

Select...

I frequently experience migraine headaches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ongoing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ongoing

This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing for reporting.

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

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor

2,869 Previous Clinical Trials

2,777,456 Total Patients Enrolled

687 Trials studying Depression

258,205 Patients Enrolled for Depression

Peter J Schmidt, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)

13 Previous Clinical Trials

3,840 Total Patients Enrolled

8 Trials studying Depression

563 Patients Enrolled for Depression

Media Library

LY500307 (ER Beta Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03689543 — Phase 2

Depression Research Study Groups: Arm 1, Arm 3, Arm 2

Depression Clinical Trial 2023: LY500307 Highlights & Side Effects. Trial Name: NCT03689543 — Phase 2

LY500307 (ER Beta Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03689543 — Phase 2

~15 spots leftby Dec 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.