RecruitingPhase 3NCT06058039

Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder


Sponsor

Neumora Therapeutics, Inc.

Enrollment

332 participants

Start Date

Dec 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of NMRA-335140 (formerly BTRX-335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 35 days), and a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo). At the completion of the 6-week Treatment Period, participants who complete the study, provide informed consent, and meet the eligibility criteria may enter an open-label extension study (NMRA-335140-501).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an oral drug called NMRA-335140 as an open-label treatment (no placebo comparison) to evaluate how safe it is and how it behaves in the body in people diagnosed with major depressive disorder (MDD). **You may be eligible if...** - You have been diagnosed with major depressive disorder without psychotic features - Your current depressive episode has been present for more than 4 weeks but no longer than 12 months - You score 25 or higher on the MADRS depression rating scale - This can be your first or a recurring episode of depression **You may NOT be eligible if...** - You have already failed 2 or more antidepressant treatments during this episode - You have a diagnosis of bipolar disorder or a psychotic disorder - You have active suicidal ideation or recent suicide attempt - You have significant medical conditions affecting liver, kidneys, or heart Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNMRA-335140

Participants will receive NMRA-335140 at a dose of 80 mg QD, orally

DRUGPlacebo

Placebo will be administered orally


Locations(71)

Neumora Investigator Site

Cerritos, California, United States

Neumora Investigator Site

Irvine, California, United States

Neumora Investigator Site

Long Beach, California, United States

Neumora Investigator Site

San Diego, California, United States

Neumora Investigator Site

San Francisco, California, United States

Neumora Investigator Site

New Haven, Connecticut, United States

Neumora Investigator Site

Brandon, Florida, United States

Neumora Investigator Site

Hialeah, Florida, United States

Neumora Investigator Site

Hialeah, Florida, United States

Neumora Investigator Site

Jacksonville, Florida, United States

Neumora Investigator Site

Miami, Florida, United States

Neumora Investigator Site

Miami, Florida, United States

Neumora Investigator site

Miami, Florida, United States

Neumora Investigator Site

Miami Beach, Florida, United States

Neumora Investigator site

Miami Springs, Florida, United States

Neumora Investigator Site

Palm Bay, Florida, United States

Neumora Investigator Site

Pembroke Pines, Florida, United States

Neumora Investigator Site

Pompano Beach, Florida, United States

Neumora Investigator Site

Saint Augustine, Florida, United States

Neumora Investigator Site

Atlanta, Georgia, United States

Neumora Investigator Site

Decatur, Georgia, United States

Neumora Investigator Site

Savannah, Georgia, United States

Neumora Investigator Site

Springfield, Massachusetts, United States

Neumora Investigator Site

St Louis, Missouri, United States

Neumora Investigator Site

Omaha, Nebraska, United States

Neumora Investigator Site

Berlin, New Jersey, United States

Neumora Investigator Site

New York, New York, United States

Neumora Investigator Site

New York, New York, United States

Neumora Investigator Site

Staten Island, New York, United States

Neumora Investigator Site

Charlotte, North Carolina, United States

Neumora Investigator Site

Austin, Texas, United States

Neumora Investigator Site

DeSoto, Texas, United States

Neumora Investigator Site

Fort Worth, Texas, United States

Neumora Investigator Site

Plano, Texas, United States

Neumora Investigator Site

Cherven Bryag, Pleven, Bulgaria

Neumora Investigator Site

Sofia, Sofia-Grad, Bulgaria

Neumora Investigator Site

Sofia, Sofia-Grad, Bulgaria

Neumora Investigator Site

Sofia, Sofia-Grad, Bulgaria

Neumora Investigator Site

Kardzhali, Bulgaria

Neumora Investigator Site

Pleven, Bulgaria

Neumora Investigator Site

Targovishte, Bulgaria

Neumora Investigator Site #1

Varna, Bulgaria

Neumora Investigator Site

Varna, Bulgaria

Neumora Investigator Site

Pilsen, Plzen, Czechia

Neumora Investigator Site

Prague, Prague, Czechia

Neumora Investigator Site #1

Kladno, South Bohemian, Czechia

Neumora Investigator Site

Kladno, Czechia

Neumora Investigator Site

Prague, Czechia

Neumora Investigator Site

Helsinki, Etelä-Suomen Lääni, Finland

Neumora Investigator Site

Turku, Etelä-Suomen Lääni, Finland

Neumora Investigator Site

Oulu, Oulun Lääni, Finland

Neumora Investigator Site

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Neumora Investigator Site

Douai, Hauts-de-France, France

Neumora Investigator Site

Montpellier, Hérault, France

Neumora Investigator Site

Angers, Maine-et-Loire, France

Neumora Investigator Site

La Roche-sur-Yon, Vendée, France

Neumora Investigator Site

Poitiers, Vienne, France

Neumora Investigator Site #1

Berlin, Germany

Neumora Investigator Site

Berlin, Germany

Neumora Investigator Site

Berlin, Germany

Neumora Investigator Site

Berlin, Germany

Neumora Investigator Site

Hamburg, Germany

Neumora Investigator Site

Suchy Las, Greater Poland Voivodeship, Poland

Neumora Investigator Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Neumora Investigator Site

Wroclaw, Lower Silesian Voivodeship, Poland

Neumora Investigator Site

Lublin, Lublin Voivodeship, Poland

Neumora Investigator Site

Lublin, Lublin Voivodeship, Poland

Neumora Investigator Site

Bialystok, Podlaskie Voivodeship, Poland

Neumora Investigator Site

Gdansk, Pomeranian Voivodeship, Poland

Neumora Investigator Site

Lund, Skåne County, Sweden

Neumora Investigator Site

Stockholm, Stockholm County, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06058039


Related Trials