RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2023-12-21
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06058039

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * Participant's current major depressive episode must be confirmed by independent assessment.
  3. * 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.
  4. * Have a MADRS total score of 25 or higher at Screening and Baseline.
  5. * A change in MADRS total score between Screening and Baseline of ≤20%.
  1. * Have failed 2 or more courses of antidepressant treatment at sufficient doses for at least 6 to 8 weeks for the current MDD episode.
  2. * 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.
  3. * Have a lifetime diagnosis of bipolar 1 or 2, schizophrenia, schizoaffective, schizophreniform, obsessive compulsive disorder, or post-traumatic stress disorder (PTSD).
  4. * Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening (excluding nicotine).
  5. * Are actively suicidal (eg, 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 ideations 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.

Contacts and Locations

Study Contact

Study Contact
CONTACT
explore@koastalstudy.com

Study Locations (Sites)

Neumora Investigator Site
Cerritos, California, 90703
United States
Neumora Investigator Site
Irvine, California, 92614
United States
Neumora Investigator Site
Long Beach, California, 90807
United States
Neumora Investigator Site
Brandon, Florida, 33511
United States
Neumora Investigator Site
Hialeah, Florida, 33012
United States
Neumora Investigator Site
Hialeah, Florida, 33016
United States
Neumora Investigator Site
Jacksonville, Florida, 32256
United States
Neumora Investigator Site
Maitland, Florida, 32751
United States
Neumora Investigator Site
Miami Beach, Florida, 33140
United States
Neumora Investigator site
Miami Springs, Florida, 33166
United States
Neumora Investigator Site
Miami, Florida, 33143
United States
Neumora Investigator Site
Miami, Florida, 33165
United States
Neumora Investigator site
Miami, Florida, 33174
United States
Neumora Investigator Site
Palm Bay, Florida, 32905
United States
Neumora Investigator Site
Pembroke Pines, Florida, 33024
United States
Neumora Investigator Site
Pompano Beach, Florida, 33060
United States
Neumora Investigator Site
Saint Augustine, Florida, 32086
United States
Neumora Investigator Site
Atlanta, Georgia, 30328
United States
Neumora Investigator Site
Decatur, Georgia, 30030
United States
Neumora Investigator Site
Savannah, Georgia, 31405
United States
Neumora Investigator Site
Springfield, Massachusetts, 01103
United States
Neumora Investigator Site
Saint Louis, Missouri, 63141
United States
Neumora Investigator Site
Omaha, Nebraska, 68112
United States
Neumora Investigator Site
Berlin, New Jersey, 08009
United States
Neumora Investigator Site
New York, New York, 10029
United States
Neumora Investigator Site
Staten Island, New York, 10310
United States
Neumora Investigator Site
Charlotte, North Carolina, 28211
United States
Neumora Investigator Site
Austin, Texas, 78759
United States
Neumora Investigator Site
Fort Worth, Texas, 76104
United States
Neumora Investigator Site
Plano, Texas, 75093
United States

Collaborators and Investigators

Sponsor: Neumora Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-21
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-12-21
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • Major Depressive Disorder
  • NMRA-335140
  • Placebo-controlled
  • Double-blind
  • Navacaprant
  • NMRA335140
  • NMRA 335140

Additional Relevant MeSH Terms

  • Major Depressive Disorder