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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I am a woman aged between 45 and 65.
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I am capable of understanding and consenting to participate.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Epidemiologic Studies-Depression Scale (CES-D)
bserver ratings - the 17-item Hamilton Rating Scale of Depression (HRSD)
Secondary outcome measures
14 item six point likert-type scale
Beck Depression Inventory (BDI)
Plasma LH, FSH, prolactin, and lipid levels
+2 more

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

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,777 Previous Clinical Trials
2,673,930 Total Patients Enrolled
665 Trials studying Depression
251,338 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please inform me about the risks associated with ER beta agonist?

"ER beta agonist is a medication that showed some promise in early stages of testing, but has not been proven effective. Power rates the safety of this drug as a 2."

Answered by AI

Which kind of patient would be most likely to benefit from enrolling in this clinical trial?

"This study, which is looking for 54 participants that suffer from depression, has certain age and medication criteria. Patients must be between 45 and 65 years old and not currently taking any mood stabilizers or sleep medications with a few exceptions (e.g. women who have discontinued menopausal hormone therapy within the 12 years prior to the study). In addition, all potential patients must have completed the screening protocol #88-M-0131 during which they will have received psychiatric, medical, and reproductive evaluations to confirm good health. Lastly, potential subjects must be of consenting age."

Answered by AI

Can people still sign up for the trial?

"The clinicaltrials.gov website indicates that this study is still enrolling patients. The listing was created on May 23rd, 2019 and was last updated on July 6th, 2022."

Answered by AI

Are researchers seeking test subjects who are 18 years of age or older for this experiment?

"Eligibility for this study is restricted to those aged 45 to 65. Out of the 1,202 total studies, 205 are for people under 18 and 997 are for seniors."

Answered by AI

How many people does this research project have the capacity to help?

"According to the latest information on clinicaltrials.gov, this study is still recruiting patients. This particular trial was posted on 5/23/2019 and last updated on 7/6/2022. They are looking for 54 individuals who meet the criteria and live near the 1 location."

Answered by AI
~21 spots leftby Dec 2025