Home › Trials › NCT06058013

Assessing the effects of NMRA-335140 on major depressive disorder

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

Phase 3 Interventional Neumora Therapeutics, Inc. · NCT06058013

This study is testing a new treatment called NMRA-335140 to see if it can help people with major depressive disorder feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment332 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorNeumora Therapeutics, Inc. Industry-sponsored
Locations69 sites (Encino, California and 68 other locations)
Trial IDNCT06058013 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of NMRA-335140, a novel treatment, compared to a placebo in individuals diagnosed with Major Depressive Disorder (MDD). It is a randomized, double-blind, placebo-controlled study involving a screening period of up to 28 days followed by a 6-week treatment phase. Participants will receive either NMRA-335140 or a placebo, and those who complete the treatment may have the opportunity to enter an open-label extension study. The study aims to provide insights into the potential benefits of NMRA-335140 for alleviating symptoms of depression.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of major depressive disorder who have experienced symptoms for more than 4 weeks but less than 12 months.

Not a fit: Patients who have failed two or more courses of antidepressant treatment for their current episode may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from major depressive disorder.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific efficacy of NMRA-335140 is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Encino, California and 68 other locations

+19 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Major Depressive DisorderNMRA-335140Placebo-controlledDouble-blindNavacaprantNMRA335140NMRA 335140
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.