What side effects are associated with this type of intervention?

Common treatments for depression, particularly those targeting neurotransmitter systems involved in mood regulation, often have side effects such as gastrointestinal issues (nausea, diarrhea), sleep disturbances (insomnia, drowsiness), sexual dysfunction, weight gain, and increased anxiety. NMDA receptor antagonists like ketamine may also cause dizziness, dissociation, and increased blood pressure.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of depression, primarily targeting neurotransmitter systems involved in mood regulation. Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, and serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, are commonly used. Tricyclic antidepressants (TCAs) like imipramine and monoamine oxidase inhibitors (MAOIs) such as phenelzine are older classes that are also effective. Atypical antidepressants, including bupropion and mirtazapine, offer alternative mechanisms of action. These drugs work by modulating the levels of neurotransmitters like serotonin, norepinephrine, and dopamine, which are crucial for mood regulation.

What other types of research exist?

Promising, novel alternatives to NMRA-335140 for depression treatment in 2024 include LY2940094, an antagonist of nociceptin receptors, and CHF3381, an NMDA receptor antagonist and MAO-A inhibitor.

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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

Are you between the ages of 18 and 65?

Do you have a primary diagnosis of major depressive disorder?

Must not have

Are you pregnant or breastfeeding?

Have you ever been diagnosed with bipolar disorder, schizophrenia, obsessive-compulsive disorder or post-traumatic stress disorder (PTSD)?

Timeline

Screening 3 weeks

Treatment Varies

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 severe depression. The study involves participants with Major Depressive Disorder and aims to find out if the medication can improve their mood by altering brain chemicals.

Who is the study for?

This trial is for adults with Major Depressive Disorder (MDD) confirmed by a specific 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. People with psychotic features or unstable conditions are excluded.

What is being tested?

The study tests the effects of NMRA-335140 on depression symptoms compared to a placebo over six weeks. Participants will be randomly assigned to either the test drug or placebo without knowing which one they receive, in multiple centers.

What are the potential side effects?

Potential side effects of NMRA-335140 aren't specified here, but common antidepressant side effects include nausea, increased anxiety, sleep disturbances, appetite changes, fatigue, dizziness and sometimes sexual dysfunction.

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 ~ Varies

Follow Up ~ baseline and up to week 6

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 QD

Group II: PlaceboPlacebo Group1 Intervention

Placebo participants will receive matching placebo tablet once daily

0 / 6Eligibility criteria met

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 often target neurotransmitter systems involved in mood regulation. Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) work by increasing the levels of serotonin and norepinephrine in the brain, which are chemicals that influence mood, emotion, and sleep. NMDA receptor antagonists, such as ketamine, act by blocking NMDA receptors, leading to a rapid antidepressant effect through enhanced synaptic plasticity and increased glutamate transmission. Understanding these mechanisms is crucial for depression patients as it helps in selecting the most effective treatment tailored to their specific neurochemical imbalances, potentially leading to faster and more sustained relief from depressive symptoms.

Molecular profile of dissociative drug ketamine in relation to its rapid antidepressant action.NMDA receptor blockade at rest triggers rapid behavioural antidepressant responses.