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NMRA-335140 for Depression

Verified Trial
Phase 3
Recruiting
Research Sponsored by Neumora Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Key
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to week 6
Awards & highlights
Pivotal Trial

Summary

This trial is studying the effects of a medication called NMRA-335140 on symptoms of depression in people with Major Depressive Disorder (MDD). The study will be conducted at multiple centers and will

Who is the study for?
This trial is for adults with Major Depressive Disorder (MDD) confirmed by a clinical interview, experiencing symptoms for more than 4 weeks but less than 12 months. They must have moderate to severe depression scores and stable symptoms between screening and baseline. Details about specific exclusions are not provided.
What is being tested?
The study tests the effects of NMRA-335140 compared to a placebo on depression symptoms over six weeks. Participants will be randomly assigned to receive either the experimental drug or placebo without knowing which one they're getting (double-blind). There's also an optional extension study afterwards.
What are the potential side effects?
Potential side effects of NMRA-335140 aren't specified here, but common antidepressant side effects can include nausea, headaches, sleep disturbances, agitation, sexual dysfunction, and increased risk of suicidal thoughts especially in young adults.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with major depression without psychosis.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Secondary study objectives
Change from Baseline to Week 6 assessed in the Snaith-Hamilton Pleasure Scale (SHAPS) total score

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NMRA-335140 80 milligrams (mg) once daily (QD)Experimental Treatment1 Intervention
Participants will receive a NMRA- 335140 tablet at a dose of 80 mg once daily (QD)
Group II: PlaceboPlacebo Group1 Intervention
Placebo participants will receive matching placebo tablet once daily.

Find a Location

Who is running the clinical trial?

Neumora Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
1,674 Total Patients Enrolled
4 Trials studying Depression
1,246 Patients Enrolled for Depression
~28 spots leftby Jan 2025
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