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NCT06029426 | COMPLETED | 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 : 383 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 : 2024-12-03
Estimated Study Completion Date : 2025-01-15

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

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United States, Albama

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Huntsville, Albama, United States, 35801

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United States, Arizona

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Phoenix, Arizona, United States, 85012

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United States, Arkansa

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Bentonville, Arkansa, United States, 72712

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United States, Arkansa

Neumor Investigator Site-1

Little Rock, Arkansa, United States, 72211

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United States, Arkansa

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Little Rock, Arkansa, United States, 72211

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United States, Arkansa

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Rogers, Arkansa, United States, 72758

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United States, California

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Bellflower, California, United States, 90706

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United States, California

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Garden Grove, California, United States, 92845

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United States, California

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Glendale, California, United States, 91206

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Imperial, California, United States, 92251

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Lafayette, California, United States, 94549

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Long Beach, California, United States, 90807

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Los Angeles, California, United States, 90015

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Oceanside, California, United States, 92056

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Orange, California, United States, 92868

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Riverside, California, United States, 92506

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San Jose, California, United States, 95124

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United States, California

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Sherman Oaks, California, United States, 91403

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United States, California

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Sherman Oaks, California, United States, 91403

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United States, California

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Theme, California, United States, 92591

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Torrance, California, United States, 90504

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United States, Colorado

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Colorado Springs, Colorado, United States, 80910

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United States, Florida

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Gainesville, Florida, United States, 32607

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United States, Florida

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Hallandale Beach, Florida, United States, 33009

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United States, Florida

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Jacksonville, Florida, United States, 32256

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United States, Florida

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Lauderhill, Florida, United States, 33319

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United States, Florida

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Maitland, Florida, United States, 32751

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United States, Florida

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Miami Lakes, Florida, United States, 33016

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United States, Florida

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Miami, Florida, United States, 33122

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United States, Florida

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Miami, Florida, United States, 33125

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United States, Florida

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Miami, Florida, United States, 33183

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United States, Florida

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Orlando, Florida, United States, 32801

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Tampa, Florida, United States, 33607

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United States, Georgia

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Marietta, Georgia, United States, 30060

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United States, Illinois

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Chicago, Illinois, United States, 60634

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Evanston, Illinois, United States, 60201

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Warrenville, Illinois, United States, 60555

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United States, Massachusetts

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Boston, Massachusetts, United States, 02116

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United States, Massachusetts

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Methuen, Massachusetts, United States, 01844

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United States, Massachusetts

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Watertown, Massachusetts, United States, 02472

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United States, Road cancer

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Bloomfield Hills, Road cancer United States, 48302

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United States, Mississippi

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Flowood, Mississippi, United States, 39232

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United States, Missouri

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Saint Charles, Missouri, United States, 63304

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United States, Nevada

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Las Vegas, Nevada, United States, 89102

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United States, New York

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Brooklyn, New York, United States, 11224

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United States, New York

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Cedarhurst, New York, United States, 11516

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United States, New York

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New York, New York, United States, 10036

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United States, New York

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Staten Island, New York, United States, 10314

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United States, Ohio

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Cleveland, Ohio, United States, 44106

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United States, Ohio

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Columbus, Ohio, United States, 43210

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United States, Ohio

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Dayton, Ohio, United States, 45417

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United States, Ohio

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Garfield Heights, Ohio, United States, 44125

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United States, Pennsylvania

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Allentown, Pennsylvania, United States, 18104

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United States, Pennsylvania

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Media, Pennsylvania, United States, 19063

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United States, Pennsylvania

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Plymouth Meeting, Pennsylvania, United States, 19462

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United States, Tennessee

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Memphis, Tennessee, United States, 38119

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United States, Texas

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Austin, Texas, United States, 78737

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Dallas, Texas, United States, 75235

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Houston, Texas, United States, 77030

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Houston, Texas, United States, 77090

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United States, Texas

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Wichita Falls, Texas, United States, 76309

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United States, Virginia

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Charlottesville, Virginia, United States, 22903

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United States, Washington

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Bellevue, Washington, United States, 98007

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United States, Washington

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Everett, Washington, United States, 98201