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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 you been diagnosed with Major Depressive Disorder?

Be older than 18 years old

Must not have

Do you struggle with substance or alcohol abuse?

Have you been diagnosed with an eating disorder?

Timeline

Screening 3 weeks

Treatment 6 weeks

Follow Up baseline and up to week 6

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called NMRA 335140 to see if it can help people with Major Depressive Disorder feel less depressed. The study involves an initial evaluation and a treatment phase where participants will receive either the medication or an inactive substance. The medication likely works by changing brain chemicals that affect mood.

Who is the study for?

This trial is for individuals with Major Depressive Disorder (MDD) confirmed by a clinical interview, experiencing symptoms for more than 4 weeks but less than 12 months. Participants must have a significant level of depression severity and haven't had two or more failed antidepressant treatments for the current episode. Excluded are those with certain other mental disorders, recent substance abuse, or serious suicidal risk.

What is being tested?

The study tests NMRA 335140's impact on depression symptoms against a placebo over six weeks. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real drug or placebo during the study. Those completing this phase may join an extension study.

What are the potential side effects?

Potential side effects aren't specified here but generally could include typical reactions to new psychiatric medications such as nausea, headaches, sleep disturbances, changes in appetite or weight, fatigue, dizziness, and possibly increased anxiety at the start.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ 6 weeks8 visits

Follow Up ~ baseline and up to week 6

Screening ~ 3 weeks

Treatment ~ 6 weeks

Follow Up ~baseline and up to week 6

This trial's timeline: 3 weeks for screening, 6 weeks 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 orally, once daily. Participants who complete the study may be eligible to participate in a separate 52-week open-label long term study.

0 / 5Eligibility criteria met