Thinking of joining a study?

Register your interest

Become a volunteer?

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

Please Choose a site

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

Not yet recruiting

United States, Albama

Neumor Site investigator

Huntsville, Albama, United States, 35801

Not yet recruiting

United States, Arizona

Neumor Site investigator

Phoenix, Arizona, United States, 85012

Not yet recruiting

United States, Arkansa

Neumor Site investigator

Bentonville, Arkansa, United States, 72712

Not yet recruiting

United States, Arkansa

Neumor Investigator Site-1

Little Rock, Arkansa, United States, 72211

Not yet recruiting

United States, Arkansa

Neumor Site investigator

Little Rock, Arkansa, United States, 72211

Not yet recruiting

United States, Arkansa

Neumor Site investigator

Rogers, Arkansa, United States, 72758

Not yet recruiting

United States, California

Neumor Site investigator

Bellflower, California, United States, 90706

Not yet recruiting

United States, California

Neumor Site investigator

Garden Grove, California, United States, 92845

Not yet recruiting

United States, California

Neumor Site investigator

Glendale, California, United States, 91206

Not yet recruiting

United States, California

Neumor Site investigator

Imperial, California, United States, 92251

Not yet recruiting

United States, California

Neumor Site investigator

Lafayette, California, United States, 94549

Not yet recruiting

United States, California

Neumor Site investigator

Long Beach, California, United States, 90807

Not yet recruiting

United States, California

Neumor Site investigator

Los Angeles, California, United States, 90015

Not yet recruiting

United States, California

Neumor Site investigator

Oceanside, California, United States, 92056

Not yet recruiting

United States, California

Neumor Site investigator

Orange, California, United States, 92868

Not yet recruiting

United States, California

Neumor Site investigator

Riverside, California, United States, 92506

Not yet recruiting

United States, California

Neumor Site investigator

San Jose, California, United States, 95124

Not yet recruiting

United States, California

Neumor Investigator Site #1

Sherman Oaks, California, United States, 91403

Not yet recruiting

United States, California

Neumor Site investigator

Sherman Oaks, California, United States, 91403

Not yet recruiting

United States, California

Neumor Site investigator

Theme, California, United States, 92591

Not yet recruiting

United States, California

Neumor Site investigator

Torrance, California, United States, 90504

Not yet recruiting

United States, Colorado

Neumor Site investigator

Colorado Springs, Colorado, United States, 80910

Not yet recruiting

United States, Florida

Neumor Site investigator

Gainesville, Florida, United States, 32607

Not yet recruiting

United States, Florida

Neumor Site investigator

Hallandale Beach, Florida, United States, 33009

Not yet recruiting

United States, Florida

Neumor Site investigator

Jacksonville, Florida, United States, 32256

Not yet recruiting

United States, Florida

Neumor Site investigator

Lauderhill, Florida, United States, 33319

Not yet recruiting

United States, Florida

Neumor Site investigator

Maitland, Florida, United States, 32751

Not yet recruiting

United States, Florida

Neumor Site investigator

Miami Lakes, Florida, United States, 33016

Not yet recruiting

United States, Florida

Neumor Site investigator

Miami, Florida, United States, 33122

Not yet recruiting

United States, Florida

Neumor Site investigator

Miami, Florida, United States, 33125

Not yet recruiting

United States, Florida

Neumor Site investigator

Miami, Florida, United States, 33183

Not yet recruiting

United States, Florida

Neumor Site investigator

Orlando, Florida, United States, 32801

Not yet recruiting

United States, Florida

Neumor Site investigator

Tampa, Florida, United States, 33607

Not yet recruiting

United States, Georgia

Neumor Site investigator

Marietta, Georgia, United States, 30060

Not yet recruiting

United States, Illinois

Neumor Site investigator

Chicago, Illinois, United States, 60634

Not yet recruiting

United States, Illinois

Neumor Site investigator

Evanston, Illinois, United States, 60201

Not yet recruiting

United States, Illinois

Neumor Site investigator

Warrenville, Illinois, United States, 60555

Not yet recruiting

United States, Massachusetts

Neumor Site investigator

Boston, Massachusetts, United States, 02116

Not yet recruiting

United States, Massachusetts

Neumor Site investigator

Methuen, Massachusetts, United States, 01844

Not yet recruiting

United States, Massachusetts

Neumor Site investigator

Watertown, Massachusetts, United States, 02472

Not yet recruiting

United States, Road cancer

Neumor Site investigator

Bloomfield Hills, Road cancer, United States, 48302

Not yet recruiting

United States, Mississippi

Neumor Site investigator

Flowood, Mississippi, United States, 39232

Not yet recruiting

United States, Missouri

Neumor Site investigator

Saint Charles, Missouri, United States, 63304

Not yet recruiting

United States, Nevada

Neumor Site investigator

Las Vegas, Nevada, United States, 89102

Not yet recruiting

United States, New York

Neumor Site investigator

Brooklyn, New York, United States, 11224

Not yet recruiting

United States, New York

Neumor Site investigator

Cedarhurst, New York, United States, 11516

Not yet recruiting

United States, New York

Neumor Site investigator

New York, New York, United States, 10036

Not yet recruiting

United States, New York

Neumor Site investigator

Staten Island, New York, United States, 10314

Not yet recruiting

United States, Ohio

Neumor Site investigator

Cleveland, Ohio, United States, 44106

Not yet recruiting

United States, Ohio

Neumor Site investigator

Columbus, Ohio, United States, 43210

Not yet recruiting

United States, Ohio

Neumor Site investigator

Dayton, Ohio, United States, 45417

Not yet recruiting

United States, Ohio

Neumor Site investigator

Garfield Heights, Ohio, United States, 44125

Not yet recruiting

United States, Pennsylvania

Neumor Site investigator

Allentown, Pennsylvania, United States, 18104

Not yet recruiting

United States, Pennsylvania

Neumor Site investigator

Media, Pennsylvania, United States, 19063

Not yet recruiting

United States, Pennsylvania

Neumor Site investigator

Plymouth Meeting, Pennsylvania, United States, 19462

Not yet recruiting

United States, Tennessee

Neumor Site investigator

Memphis, Tennessee, United States, 38119

Not yet recruiting

United States, Texas

Neumor Site investigator

Austin, Texas, United States, 78737

Not yet recruiting

United States, Texas

Neumor Site investigator

Dallas, Texas, United States, 75235

Not yet recruiting

United States, Texas

Neumor Site investigator

Houston, Texas, United States, 77030

Not yet recruiting

United States, Texas

Neumor Site investigator

Houston, Texas, United States, 77090

Not yet recruiting

United States, Texas

Neumor Site investigator

Wichita Falls, Texas, United States, 76309

Not yet recruiting

United States, Virginia

Neumor Site investigator

Charlottesville, Virginia, United States, 22903

Not yet recruiting

United States, Washington

Neumor Site investigator

Bellevue, Washington, United States, 98007

Not yet recruiting

United States, Washington

Neumor Site investigator

Everett, Washington, United States, 98201