650 Participants Needed

NMRA-335140 for Depression

Recruiting at 109 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Neumora Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that you must comply with medication restrictions from the parent study. It's best to discuss your current medications with the study team to understand any specific requirements.

What makes the drug NMRA-335140 unique for treating depression?

NMRA-335140, also known as Navacaprant, is unique because it may target the glutamatergic system, which is involved in rapid antidepressant effects, unlike traditional antidepressants that primarily affect monoamine neurotransmitters like serotonin and dopamine.12345

What data supports the effectiveness of the drug NMRA-335140 for depression?

Research suggests that drugs targeting the glutamatergic system, like NMDA receptor antagonists, have shown antidepressant properties by promoting new synaptic connections and reversing stress-induced changes in the brain. This indicates potential effectiveness for NMRA-335140, which may work through similar mechanisms.12356

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have consented to participation in this study via the completion of an ICF.
You are willing to follow the associated medication/therapy rules outlined in the document.
You have successfully concluded a Phase 3 MDD study (NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303) as dictated by the provisions of the source protocol.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NMRA-335140 at a dose of 80 mg once daily during a 52-week treatment period

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Open-label extension

Participants continue to receive NMRA-335140 to assess long-term safety and effectiveness

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NMRA-335140
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: NMRA-335140 80 milligrams (mg) once daily (QD)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Neumora Therapeutics, Inc.

Lead Sponsor

Trials
7
Recruited
2,100+

Published Research Related to This Trial

In a 52-week study involving 813 patients with major depressive disorder who had inadequate responses to previous treatments, dexmecamylamine was found to be generally safe and tolerable when used alongside SSRIs/SNRIs.
While 82.4% of patients on dexmecamylamine experienced adverse events, the most common were mild, such as constipation and dizziness, and overall safety profiles were consistent with earlier studies, indicating it may be a viable adjunct treatment option.
Safety and tolerability of dexmecamylamine (TC-5214) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to antidepressant therapy: results of a long-term study.Tummala, R., Desai, D., Szamosi, J., et al.[2022]
Current antidepressant treatments for major depressive disorder (MDD) and bipolar disorder (BD) often have delayed effects and limited efficacy, primarily targeting monoamine systems, while novel glutamate receptor modulators show promise for faster-acting antidepressant effects.
Ketamine, a non-competitive NMDA receptor antagonist, has demonstrated rapid and robust antidepressant effects, leading to the exploration of other NMDA antagonists and glutamate modulators, which may offer similar or improved therapeutic benefits.
New targets for rapid antidepressant action.Machado-Vieira, R., Henter, ID., Zarate, CA.[2022]
Ketamine has shown a unique fast-acting neuroprotective and antidepressant effect by targeting the glutamatergic system, suggesting that glutamate plays a significant role in treating major depression.
Emerging treatments, including NMDA receptor antagonists and AMPA agonists, have demonstrated the ability to promote new synaptic connections and reverse stress-induced neuronal changes, indicating a promising direction for future antidepressant drug development.
Role of calcium, glutamate and NMDA in major depression and therapeutic application.Deutschenbaur, L., Beck, J., Kiyhankhadiv, A., et al.[2015]

Citations

Safety and tolerability of dexmecamylamine (TC-5214) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to antidepressant therapy: results of a long-term study. [2022]
New targets for rapid antidepressant action. [2022]
Role of calcium, glutamate and NMDA in major depression and therapeutic application. [2015]
Alterations in amino acid levels in mouse brain regions after adjunctive treatment of brexpiprazole with fluoxetine: comparison with (R)-ketamine. [2018]
Efficacy and tolerability of flexibly-dosed adjunct TC-5214 (dexmecamylamine) in patients with major depressive disorder and inadequate response to prior antidepressant. [2022]
Prolonged administration of antidepressant drugs leads to increased binding of [(3)H]MPEP to mGlu5 receptors. [2018]
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