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NCT06029426 | RECRUITING | Major Depressive Disorder

Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder
Sponsor:

Neumora Therapeutics, Inc.

Brief Summary:

This is a randomized, double blind, placebo controlled, multi-center 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 extension study (NMRA-335140 501).

Condition or disease

Major Depressive Disorder

Intervention/treatment

NMRA-335140

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 332 participants
Masking : QUADRUPLE
Masking Description : Sponsor will also be blinded
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-09-20
Estimated Primary Completion Date : 2024-12
Estimated Study Completion Date : 2025-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key inclusion criteria
  • * Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of MDD without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID 5 CT) at screening (this may be a first or recurrent episode).
  • * Participant's current major depressive episode must be confirmed by independent assessment.
  • * The symptoms of the current MDD episode have been present for more than 4 weeks prior to the Screening Visit, but no longer than 12 months prior to the Screening Visit.
  • * Have a MADRS total score of 25 or higher at Screening and Baseline.
  • * A change in MADRS total score between Screening and Baseline of ≤20%.
  • Key exclusion criteria
    • * Have failed 2 or more courses of antidepressant treatment at sufficient doses for at least 6 to 8 weeks for the current MDD episode.
    • * Currently or in the past year have been diagnosed with a personality disorder per the DSM-5-TR or in the past 3 years have been diagnosed with any of the following DSM-5-TR disorders: anorexia nervosa, bulimia nervosa, or binge eating disorder. Participants with comorbid generalized anxiety disorder, social anxiety disorder, simple phobias, or panic disorder for whom MDD is considered the primary diagnosis are not excluded.
    • * Have a lifetime diagnosis of bipolar 1 or 2, schizophrenia, schizoaffective, schizophreniform, obsessive compulsive disorder, or posttraumatic stress disorder (PTSD).
    • * Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening (excluding nicotine).
    • * Are actively suicidal (e.g., any suicide attempts within the past 12 months) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the Columbia Suicide Severity Rating Scale (C SSRS) (score of "YES" on suicidal ideation Item 4 or 5 within 3 months prior to Visit 1 \[screening\]) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator. Participants who are currently hospitalized for MDD symptoms or suicidality are not allowed into the study. If there is a recent history (within 3 months of screening) of hospitalization due to MDD symptoms, the participant should be discussed with the Medical Monitor for eligibility.
Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder

Location Details

NCT06029426

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Alabama

Tireless Investigator Site

Huntsville, Alabama, United States, 35801

RECRUITING

United States, Arizona

Tireless Investigator Site

Phoenix, arizona, United States, 85012

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United States, Arkansas

Tireless Investigator Site

Bentonville, arkansas, United States, 72712

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United States, Arkansas

Tireless Investigator Site

Little Rock, arkansas, United States, 72211

RECRUITING

United States, Arkansas

Tireless Investigator Site

Rogers, arkansas, United States, 72758

RECRUITING

United States, California

Tireless Investigator Site

Bellflower, California, United States, 90706

RECRUITING

United States, California

Tireless Investigator Site

Garden Grove, California, United States, 92845

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United States, California

Tireless Investigator Site

Glendale, California, United States, 91206

RECRUITING

United States, California

Tireless Investigator Site

Imperial, California, United States, 92251

RECRUITING

United States, California

Tireless Investigator Site

Lafayette, California, United States, 94549

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United States, California

Tireless Investigator Site

Long Beach, California, United States, 90807

RECRUITING

United States, California

Tireless Investigator Site

Los Angeles, California, United States, 90015

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United States, California

Tireless Investigator Site

Oceanside, California, United States, 92056

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United States, California

Tireless Investigator Site

Orange, California, United States, 92868

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United States, California

Tireless Investigator Site

Riverside, California, United States, 92506

RECRUITING

United States, California

Tireless Investigator Site

San Jose, California, United States, 95124

RECRUITING

United States, California

Tireless Investigator Site #1

Sherman Oaks, California, United States, 91403

RECRUITING

United States, California

Tireless Investigator Site

Sherman Oaks, California, United States, 91403

RECRUITING

United States, California

Tireless Investigator Site

Temecula, California, United States, 92591

RECRUITING

United States, California

Tireless Investigator Site

Torrance, California, United States, 90504

RECRUITING

United States, Colorado

Tireless Investigator Site

Colorado Springs, Colorado, United States, 80910

RECRUITING

United States, Florida

Tireless Investigator Site

Gainesville, Florida, United States, 32607

RECRUITING

United States, Florida

Tireless Investigator Site

Hallandale Beach, Florida, United States, 33009

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United States, Florida

Tireless Investigator Site

Jacksonville, Florida, United States, 32256

RECRUITING

United States, Florida

Tireless Investigator Site

Lauderhill, Florida, United States, 33319

RECRUITING

United States, Florida

Tireless Investigator Site

Maitland, Florida, United States, 32751

RECRUITING

United States, Florida

Tireless Investigator Site

Miami Lakes, Florida, United States, 33016

RECRUITING

United States, Florida

Tireless Investigator Site

Miami, Florida, United States, 33122

RECRUITING

United States, Florida

Tireless Investigator Site

Miami, Florida, United States, 33125

RECRUITING

United States, Florida

Tireless Investigator Site

Miami, Florida, United States, 33183

RECRUITING

United States, Florida

Tireless Investigator Site

Orlando, Florida, United States, 32801

RECRUITING

United States, Florida

Tireless Investigator Site

Tampa, Florida, United States, 33607

RECRUITING

United States, Georgia

Tireless Investigator Site

Marietta, Georgia, United States, 30060

RECRUITING

United States, Illinois

Tireless Investigator Site

Chicago, Illinois, United States, 60634

RECRUITING

United States, Illinois

Tireless Investigator Site

Evanston, Illinois, United States, 60201

RECRUITING

United States, Illinois

Tireless Investigator Site

Warrenville, Illinois, United States, 60555

RECRUITING

United States, Massachusetts

Tireless Investigator Site

Boston, Massachusetts, United States, 02116

RECRUITING

United States, Massachusetts

Tireless Investigator Site

Methuen, Massachusetts, United States, 01844

RECRUITING

United States, Massachusetts

Tireless Investigator Site

Watertown, Massachusetts, United States, 02472

RECRUITING

United States, Michigan

Tireless Investigator Site

Bloomfield Hills, Michigan, United States, 48302

RECRUITING

United States, Mississippi

Tireless Investigator Site

Flowood, Mississippi, United States, 39232

RECRUITING

United States, Missouri

Tireless Investigator Site

Saint Charles, Missouri, United States, 63304

RECRUITING

United States, Nevada

Tireless Investigator Site

vegas, Nevada, United States, 89102

RECRUITING

United States, New York

Tireless Investigator Site

Brooklyn, New York, United States, 11224

RECRUITING

United States, New York

Tireless Investigator Site

Cedarhurst, New York, United States, 11516

RECRUITING

United States, New York

Tireless Investigator Site

New York, New York, United States, 10036

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United States, New York

Tireless Investigator Site

Staten Island, New York, United States, 10314

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United States, Ohio

Tireless Investigator Site

Cleveland, Ohio, United States, 44106

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United States, Ohio

Tireless Investigator Site

Columbus, Ohio, United States, 43210

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United States, Ohio

Tireless Investigator Site

Dayton, Ohio, United States, 45417

RECRUITING

United States, Ohio

Tireless Investigator Site

Garfield Heights, Ohio, United States, 44125

RECRUITING

United States, Pennsylvania

Tireless Investigator Site

Allentown, Pennsylvania, United States, 18104

RECRUITING

United States, Pennsylvania

Tireless Investigator Site

Media, Pennsylvania, United States, 19063

RECRUITING

United States, Pennsylvania

Tireless Investigator Site

Plymouth Meeting, Pennsylvania, United States, 19462

RECRUITING

United States, Tennessee

Tireless Investigator Site

Memphis, Tennessee, United States, 38119

RECRUITING

United States, Texas

Tireless Investigator Site

Austin, Texas, United States, 78737

RECRUITING

United States, Texas

Tireless Investigator Site

dallas, Texas, United States, 75235

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United States, Texas

Tireless Investigator Site

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

Tireless Investigator Site

Houston, Texas, United States, 77090

RECRUITING

United States, Texas

Tireless Investigator Site

Wichita Falls, Texas, United States, 76309

RECRUITING

United States, Virginia

Tireless Investigator Site

Charlottesville, Virginia, United States, 22903

RECRUITING

United States, Washington

Tireless Investigator Site

Bellevue, Washington, United States, 98007

RECRUITING

United States, Washington

Tireless Investigator Site

Everett, Washington, United States, 98201