NMRA 335140 for Depression

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Neumora Therapeutics, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called NMRA 335140 to see if it can help people with Major Depressive Disorder feel less depressed. The study involves an initial evaluation and a treatment phase where participants will receive either the medication or an inactive substance. The medication likely works by changing brain chemicals that affect mood.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that NMRA 335140 for Depression is an effective drug?

The available research does not provide any data supporting the effectiveness of NMRA 335140 for treating depression. The studies mentioned focus on other treatments and drugs, such as TC-5214, nitrous oxide, brexpiprazole, and ketamine, but do not include any information or results related to NMRA 335140. Therefore, there is no evidence from the provided information to suggest that NMRA 335140 is an effective treatment for depression. ^{1 2 3 4 5}

What safety data is available for NMRA 335140 (Navacaprant) in treating depression?

The provided research does not contain specific safety data for NMRA 335140 (Navacaprant) or its other names like BTRX-140, BTRX-335140, CYM-53093, NMRA-140. The studies focus on other NMDA antagonists and their safety profiles in different contexts, such as stroke and neurosurgery patients, or as adjuncts in depression treatment. Therefore, no direct safety data for NMRA 335140 is available in the provided research. ^{6 7 8 9 10}

Is the drug NMRA 335140 a promising treatment for depression?

Yes, NMRA 335140 is a promising drug for depression because it targets the glutamate system, which is linked to fast-acting antidepressant effects. This approach is different from traditional antidepressants and could offer quicker relief for patients. ^{10 11 12 13 14}

Research Team

Eligibility Criteria

This trial is for individuals with Major Depressive Disorder (MDD) confirmed by a clinical interview, experiencing symptoms for more than 4 weeks but less than 12 months. Participants must have a significant level of depression severity and haven't had two or more failed antidepressant treatments for the current episode. Excluded are those with certain other mental disorders, recent substance abuse, or serious suicidal risk.

Inclusion Criteria

Have you been diagnosed with Major Depressive Disorder?

Exclusion Criteria

Do you struggle with substance or alcohol abuse?

Have you been diagnosed with an eating disorder?

Have you tried at least 2 antidepressants that haven't worked?

Treatment Details

Interventions

• NMRA 335140 (Other)

Trial Overview The study tests NMRA 335140's impact on depression symptoms against a placebo over six weeks. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real drug or placebo during the study. Those completing this phase may join an extension study.

Participant Groups

Group I: NMRA-335140 80 milligrams (mg) once daily (QD) Experimental Treatment 1 Intervention

Participants will receive a NMRA-335140 tablet at a dose of 80 mg once daily (QD)

Group II: Placebo Placebo Group 1 Intervention

Placebo participants will receive matching placebo tablet orally, once daily. Participants who complete the study may be eligible to participate in a separate 52-week open-label long term study.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Neumora Investigator Site Huntsville, AL

Neumora Investigator Site Phoenix, AZ

Neumora Investigator Site Bentonville, AR

Neumora Investigator Site Little Rock, AR

More Trial Locations

Who Is Running the Clinical Trial?

Neumora Therapeutics, Inc.

Lead Sponsor

Trials

7

Patients Recruited

2,100+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of flexibly-dosed adjunct TC-5214 (dexmecamylamine) in patients with major depressive disorder and inadequate response to prior antidepressant. Vieta, E., Thase, ME., Naber, D., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nitrous Oxide for Treatment-Resistant Major Depression: A Proof-of-Concept Trial. Nagele, P., Duma, A., Kopec, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alterations in amino acid levels in mouse brain regions after adjunctive treatment of brexpiprazole with fluoxetine: comparison with (R)-ketamine. Ma, M., Ren, Q., Fujita, Y., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic variables of the glutamatergic system associated with treatment-resistant depression: A review of the literature. Saez, E., Erkoreka, L., Moreno-Calle, T., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The involvement of AMPA-ERK1/2-BDNF pathway in the mechanism of new antidepressant action of prokinetic meranzin hydrate. Xie, Y., Huang, X., Hu, SY., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of the low-affinity, use-dependent NMDA antagonist AR-R15896AR in stroke patients: a dose-ranging study. Lees, KR., Dyker, AG., Sharma, A., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MK-801, memantine and amantadine show neuroprotective activity in the nucleus basalis magnocellularis. Wenk, GL., Danysz, W., Mobley, SL.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose escalation safety and tolerance study of the N-methyl-D-aspartate antagonist dextromethorphan in neurosurgery patients. Steinberg, GK., Bell, TE., Yenari, MA.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New targets for rapid antidepressant action. Machado-Vieira, R., Henter, ID., Zarate, CA.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of calcium, glutamate and NMDA in major depression and therapeutic application. Deutschenbaur, L., Beck, J., Kiyhankhadiv, A., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Modulation of Glutamate Receptors in Major Depressive Disorder. Jaso, BA., Niciu, MJ., Iadarola, ND., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NMDA receptors as therapeutic targets for depression treatment: Evidence from clinical to basic research. Lv, S., Yao, K., Zhang, Y., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levomilnacipran (Fetzima): A New Serotonin-Norepinephrine Reuptake Inhibitor for the Treatment of Major Depressive Disorder. Saraceni, MM., Venci, JV., Gandhi, MA.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of flexibly-dosed adjunct TC-5214 (dexmecamylamine) in patients with major depressive disorder and inadequate response to prior antidepressant. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Nitrous Oxide for Treatment-Resistant Major Depression: A Proof-of-Concept Trial. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Alterations in amino acid levels in mouse brain regions after adjunctive treatment of brexpiprazole with fluoxetine: comparison with (R)-ketamine. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Genetic variables of the glutamatergic system associated with treatment-resistant depression: A review of the literature. [2022]

5. Austria pubmed.ncbi.nlm.nih.gov

The involvement of AMPA-ERK1/2-BDNF pathway in the mechanism of new antidepressant action of prokinetic meranzin hydrate. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Tolerability of the low-affinity, use-dependent NMDA antagonist AR-R15896AR in stroke patients: a dose-ranging study. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

MK-801, memantine and amantadine show neuroprotective activity in the nucleus basalis magnocellularis. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Dose escalation safety and tolerance study of the N-methyl-D-aspartate antagonist dextromethorphan in neurosurgery patients. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

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]

10. England pubmed.ncbi.nlm.nih.gov

New targets for rapid antidepressant action. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Role of calcium, glutamate and NMDA in major depression and therapeutic application. [2015]

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Therapeutic Modulation of Glutamate Receptors in Major Depressive Disorder. [2023]

13. England pubmed.ncbi.nlm.nih.gov

NMDA receptors as therapeutic targets for depression treatment: Evidence from clinical to basic research. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Levomilnacipran (Fetzima): A New Serotonin-Norepinephrine Reuptake Inhibitor for the Treatment of Major Depressive Disorder. [2022]