RecruitingPhase 3NCT06058013

Study to Assess the Effects of Oral NMRA-335140 Versus Placebo 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 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, double-blind, placebo-controlled, multicenter study to 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 28 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 a new oral drug called NMRA-335140 (compared to placebo) to see if it can reduce symptoms of major depressive disorder (MDD) — a serious form of depression. This is a randomized, controlled trial, meaning participants are randomly assigned to receive the drug or a placebo. **You may be eligible if...** - You have been diagnosed with major depressive disorder without psychotic features - Your current depressive episode has lasted between 4 weeks and 12 months - You score 25 or higher on the MADRS depression scale (a measure of depression severity) - This may be your first or a recurrent episode of depression **You may NOT be eligible if...** - You have failed 2 or more antidepressant treatments in this episode - You have bipolar disorder, schizophrenia, or other psychotic conditions - You have active suicidal ideation - You have significant liver, kidney, or heart conditions 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.

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Interventions

DRUGNMRA-335140

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

DRUGPlacebo

Placebo will be administered orally


Locations(74)

Neumora Investigator Site

Encino, California, United States

Neumora Investigator Site

Garden Grove, California, United States

Neumora Investigator Site

Los Alamitos, California, United States

Neumora Investigator Site

Newport Beach, California, United States

Neumora Investigator Site

Orange, California, United States

Neumora Investigator Site

Santa Ana, California, United States

Neumora Investigator Site

Norwalk, Connecticut, United States

Neumora Investigator Site

Bradenton, Florida, United States

Neumora Investigator Site

Hollywood, Florida, United States

Neumora Investigator Site

Homestead, Florida, United States

Neumora Investigator Site

Lauderhill, Florida, United States

Neumora Investigator Site

Maitland, Florida, United States

Neumora Investigator Sites

Miami, 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, Florida, United States

Neumora Investigator Site

Miami Lakes, Florida, United States

Neumora Investigator Site

Miami Lakes, Florida, United States

Neumora Investigator Site

Orlando, Florida, United States

Neumora Investigator Site

Orlando, Florida, United States

Neumora Investigator Site

Orlando, Florida, United States

Neumora Investigator Site

Pinellas Park, Florida, United States

Neumora Investigator Site

Pompano Beach, Florida, United States

Neumora Investigator Site

Tampa, Florida, United States

Neumora Investigator Site#1

Tampa, Florida, United States

Neumora Investigator Site

Tampa, Florida, United States

Neumora Investigator Site

Atlanta, Georgia, United States

Neumora Investigator Site

Atlanta, Georgia, United States

Neumora Investigator Site

Atlanta, Georgia, United States

Neumora Investigator Site

Marrero, Louisiana, United States

Neumora Investigator Site

New Orleans, Louisiana, United States

Neumora Investigator Site

Baltimore, Maryland, United States

Neumora Investigator Site

Towson, Maryland, United States

Neumora Investigator Site

Boston, Massachusetts, United States

Neumora Investigator Site

Boston, Massachusetts, United States

Neumora Investigator Site

Watertown, Massachusetts, United States

Neumora Investigator Site

Mankato, Minnesota, United States

Neumora Investigator Site

Princeton, New Jersey, United States

Neumora Investigator Site

Toms River, New Jersey, United States

Neumora Investigator Site

Albuquerque, New Mexico, United States

Neumora Investigator Site

Buffalo, New York, United States

Neumora Investigator Site

Inwood, New York, United States

Neumora Investigator Site

New York, New York, United States

Neumora Investigator Site

The Bronx, New York, United States

Neumora Investigator Site

Monroe, North Carolina, United States

Neumora Investigator Site

North Canton, Ohio, United States

Neumora Investigator site

Edmond, Oklahoma, United States

Neumora Investigator Site

Oklahoma City, Oklahoma, United States

Neumora Investigator Site

Philadelphia, Pennsylvania, United States

Neumora Investigator Site

North Charleston, South Carolina, United States

Neumora Investigator Site

Memphis, Tennessee, United States

Neumora Investigator Site

Austin, Texas, United States

Neumora Investigator Site

Dallas, Texas, United States

Neumora Investigator Site

Houston, Texas, United States

Neumora Investigator Site

Bellevue, Washington, United States

Neumora Investigator Site

Everett, Washington, United States

Neumora Investigator Site

Curitiba, Paraná, Brazil

Neumora Investigator Site

Porto Alegre, Rio Grande do Sul, Brazil

Neumora Investigator Site

Santa Cecília, São Paulo, Brazil

Neumora Investigator Site

São Bernardo do Campo, São Paulo, Brazil

Neumora Investigator Site

São José do Rio Preto, São Paulo, Brazil

Neumora Investigator Site

Rio de Janeiro, Brazil

Neumora Investigator Site

São Paulo, Brazil

Neumora Investigator Site

Kelowna, British Columbia, Canada

Neumora Investigator Site

Hamilton, Ontario, Canada

Neumora Investigator site

Markham, Ontario, Canada

Neumora Investigator Site

Toronto, Ontario, Canada

Neumora Investigator Site

Toronto, Ontario, Canada

Neumora Investigator Site

Santiago, Santiago Metropolitan, Chile

Neumora Investigator Site

Santiago, Santiago Metropolitan, Chile

Neumora Investigator Site

Antofagasta, Chile

Neumora Investigator Site

Santiago, Chile

Neumora Investigator Site

Santiago, Chile

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