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Assessing the safety and effectiveness of NMRA-335140 for major depressive disorder

Long-term Study to Assess the Safety and Effectiveness of NMRA-335140 in Participants With Major Depressive Disorder

Phase 3 Interventional Neumora Therapeutics, Inc. · NCT06029439

This study is testing a new medication called NMRA-335140 to see if it is safe and effective for people with major depressive disorder over a year.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorNeumora Therapeutics, Inc. Industry-sponsored
Locations178 sites (Huntsville, Alabama and 177 other locations)
Trial IDNCT06029439 on ClinicalTrials.gov

What this trial studies

This is a 52-week open-label extension study evaluating the safety, tolerability, and effectiveness of NMRA-335140 in participants with major depressive disorder (MDD). Eligible participants are those who have completed a previous Phase 3 study involving NMRA-335140 and meet specific inclusion criteria. The study aims to gather long-term data on the treatment's efficacy and safety profile. Participants will be monitored throughout the study to assess their response to the medication.

Who should consider this trial

Good fit: Ideal candidates are individuals who have previously participated in a Phase 3 study of NMRA-335140 and meet the eligibility criteria.

Not a fit: Patients with other significant mental health disorders that were exclusionary in the parent studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new long-term treatment option for patients suffering from major depressive disorder.

How similar studies have performed: Other studies involving NMRA-335140 have shown promise, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

Rollover participants are eligible for the study if the following inclusion criteria are met:

* Completed a previous NMRA-335140 Phase 3 MDD study (example: NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303) according to the completion definition in the parent study protocol.
* Signed an informed consent form (ICF) for this study.
* Willing to comply with the contraception requirements described in the inclusion criteria of the parent study protocol.
* Willing to comply with the concomitant medication/therapy restrictions described in the exclusion criteria of the parent study protocol.

Key Exclusion Criteria:

Rollover participants are excluded from the study if any of the following exclusion criteria are met:

* Diagnosed with another Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder that would have been exclusionary in the parent study (eg, personality disorder, bipolar 1 or 2, schizophrenia, any other psychotic disorder, or moderate or severe substance or alcohol use disorder \[excluding nicotine\]).
* Considered to be at significant risk of suicide in the judgment of the Investigator. This includes participants who are actively suicidal (eg, any suicide attempts during the parent study) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the C-SSRS ("Since Last Visit" version, score of "YES" on suicidal ideation Item 4 or 5) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator.
* Non-adherent with study medication (took ≤70% of study drug over any 2-week visit interval) or procedures during the parent study.
* Experienced treatment emergent adverse events (TEAEs) considered related to the study medication from the parent study and judged by the Investigator to be clinically significant to render the participant ineligible for enrollment.
* Have an abnormality on ocular examination that would prohibit continued study participation as determined by the Investigator.
* Use of disallowed concomitant medication or therapy that would have been exclusionary in the parent study, may compromise the safety of the participant, and/or confound the interpretation of protocol assessments.
* Considered by the Investigator to be inappropriate for any other reason.

Where this trial is running

Huntsville, Alabama and 177 other locations

+128 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-335140Long-termSafetyEfficacyNavacaprantNMRA335140NMRA 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.