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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 54 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new medication called NMRA-335140 to see if it helps people with major depressive disorder. It includes participants who have no safety concerns. The medication aims to improve mood by affecting brain chemicals.
Who is the study for?
This trial is for people who have major depressive disorder and completed a previous NMRA-335140 study. They must have signed an informed consent form, agree to follow medication restrictions, and comply with contraception requirements from the earlier study.
What is being tested?
The trial is testing the safety and effectiveness of a drug called NMRA-335140 over 52 weeks in participants with major depressive disorder who previously took part in related studies.
What are the potential side effects?
Since this summary does not provide specific side effects of NMRA-335140, it's important for interested individuals to ask about potential risks before joining.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 54 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 54 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and tolerability assessments based on Treatment Emergent Adverse Events (TEAEs) and validated clinical scales
Secondary study objectives
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score over time.
Change from Baseline in PHQ-9 Anhedonia Item #1 over time.
Change from Baseline in the Clinical Global Impression Scale of Severity (CGI-S)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
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) during a 52-week treatment period.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression, such as SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), work by increasing the levels of neurotransmitters like serotonin and norepinephrine in the brain, which are often imbalanced in depression. Novel treatments, like NMRA-335140, may target different pathways, such as glutamatergic systems, to provide rapid and sustained antidepressant effects.
Understanding these mechanisms is crucial for depression patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects.
Rapid-acting glutamatergic antidepressants: the path to ketamine and beyond.Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders?
Rapid-acting glutamatergic antidepressants: the path to ketamine and beyond.Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders?
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Who is running the clinical trial?
Neumora Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
1,356 Total Patients Enrolled
4 Trials studying Depression
928 Patients Enrolled for Depression