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NMRA-335140 for Bipolar Depression

Phase 2
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 DSM-5-TR diagnosis of BP II disorder with a current MDE, without psychotic features confirmed by SCID-5-CT at screening
Be older than 18 years old
Must not have
Have failed 2 or more courses of antidepressant or mood stabilizer/antipsychotic treatment for treatment of depressive symptoms in the current MDE
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to week 6
Awards & highlights

Summary

"This trial will test the impact of NMRA-335140 on depression symptoms in adults with Bipolar II disorder. Participants will either receive NMRA-335140 or a placebo over a 6-week

Who is the study for?
This trial is for adults with Bipolar II Disorder who are currently experiencing symptoms of major depression. Participants must have a stable condition without rapid mood changes and be able to take oral medication. They should not be on certain other medications or therapies for bipolar disorder during the trial.
What is being tested?
The study tests NMRA-335140, a potential new treatment for depression in those with Bipolar II Disorder, against a placebo (a pill without active medicine). It's randomized and double-blind, meaning neither participants nor researchers know who gets the real drug or placebo.
What are the potential side effects?
Potential side effects of NMRA-335140 may include nausea, headache, dizziness, fatigue, changes in appetite or weight. The exact side effects aren't listed but typically align with common reactions to psychiatric medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Bipolar II disorder and am currently experiencing a major depressive episode without psychosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I've tried at least 2 different treatments for depression that didn't work.

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

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

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 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
1,946 Total Patients Enrolled
~40 spots leftby Dec 2025
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