What side effects are associated with this type of intervention?

Common treatments for depression, such as SSRIs (e.g., fluoxetine, sertraline), SNRIs (e.g., venlafaxine, duloxetine), and atypical antidepressants (e.g., bupropion, mirtazapine), have a range of side effects. SSRIs often cause gastrointestinal issues, insomnia, sexual dysfunction, and weight changes. SNRIs can lead to similar side effects, including increased blood pressure and heart rate. Atypical antidepressants may cause dry mouth, dizziness, and weight gain. All antidepressants can potentially cause withdrawal symptoms if discontinued abruptly, including agitation, anxiety, and flu-like symptoms. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment to individual needs.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of major depressive disorder (MDD), including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, and atypical antidepressants like bupropion and mirtazapine. These medications primarily work by altering neurotransmitter levels in the brain to improve mood and alleviate depressive symptoms. NMRA-335140, currently under study, likely shares a similar mechanism of action aimed at modulating neurotransmitter activity to treat MDD.

What other types of research exist?

Promising novel alternatives to NMRA-335140 for the treatment of major depressive disorder include: 1) Ketamine and its derivatives (e.g., esketamine), which act as NMDA receptor antagonists and have shown rapid antidepressant effects. 2) Lu AA33810, a neuropeptide Y Y5 receptor antagonist, which has demonstrated antidepressant-like activity and glioprotective effects. 3) Psychedelic-assisted therapies, such as psilocybin, which are being investigated for their potential to induce rapid and sustained antidepressant effects through serotonin receptor modulation.

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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 week 54

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 week 54

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 54

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 54 for reporting.

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)

+7 more

Awards & 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.

Do I qualify?Apply below to find out

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?