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

Launched by NEUMORA THERAPEUTICS, INC. · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called NMRA-335140 to see how well it helps people with Major Depressive Disorder (MDD). Participants in the study will be randomly assigned to receive either the new medication or a placebo (a pill that looks like the medication but has no active ingredients) for six weeks. The goal is to find out if NMRA-335140 can improve symptoms of depression compared to the placebo. Before starting, participants will go through a screening period to ensure they qualify based on specific criteria.

To be eligible for this study, participants should be between the ages of 18 and 65 and have been diagnosed with MDD, meaning they experience persistent feelings of sadness or a lack of interest in activities for more than four weeks. They must also have a certain level of depression severity as measured by a standardized scale. However, individuals with a history of certain mental health disorders, serious substance abuse issues, or those who are actively suicidal cannot participate. During the trial, participants will visit the study center regularly, where they will provide feedback about their symptoms and well-being. After the initial six weeks, those who complete the study may have the option to continue receiving the medication in an extended phase.

Gender

ALL

Eligibility 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 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 post traumatic 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 (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 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.