← Back to Search

Other

NMRA-335140 80 milligrams (mg) once daily (QD) 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
Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of MDD without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID 5 CT) at screening (this may be a first or recurrent episode).
Key
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to week 6
Awards & highlights

Study Summary

This trial is studying the effects of a medication called NMRA-335140 on symptoms of depression in people with Major Depressive Disorder (MDD). The study will be conducted at multiple centers and will

Who is the study for?
This trial is for adults with Major Depressive Disorder (MDD) confirmed by a clinical 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. Details about specific exclusions are not provided.Check my eligibility
What is being tested?
The study tests the effects of NMRA-335140 compared to a placebo on depression symptoms over six weeks. Participants will be randomly assigned to receive either the experimental drug or placebo without knowing which one they're getting (double-blind). There's also an optional extension study afterwards.See study design
What are the potential side effects?
Potential side effects of NMRA-335140 aren't specified here, but common antidepressant side effects can include nausea, headaches, sleep disturbances, agitation, sexual dysfunction, and increased risk of suicidal thoughts especially in young adults.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with major depression without psychosis.
Select...
It seems like the criterion you've mentioned is incomplete. Could you please provide more details or context so that I can assist you accurately?

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Secondary outcome measures
Change from Baseline to Week 6 assessed in the Snaith-Hamilton Pleasure Scale (SHAPS) total score

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 once daily (QD)
Group II: PlaceboPlacebo Group1 Intervention
Placebo participants will receive matching placebo tablet once daily.

Find a Location

Who is running the clinical trial?

Neumora Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
1,518 Total Patients Enrolled
4 Trials studying Depression
1,518 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration granted approval for the daily administration of NMRA-335140 at a dosage of 80 milligrams?

"Based on the fact that this trial is in Phase 3 and has accumulated substantial safety data, our team at Power assigns a safety rating of 3 to NMRA-335140 administered at a dose of 80 mg once daily."

Answered by AI

Are individuals currently able to apply and participate in this ongoing medical trial?

"As per the information provided on clinicaltrials.gov, this trial is presently seeking eligible participants. The initial posting of the study occurred on December 20th, 2023, and it was most recently updated on December 27th, 2023."

Answered by AI

What is the upper limit on the number of participants who can be enrolled in this research endeavor?

"Indeed, the information provided on clinicaltrials.gov confirms that this clinical trial is actively seeking participants. The study was initially posted on December 20, 2023, and underwent its most recent update on December 27, 2023. Recruitment aims to enroll a total of 332 patients from a single location."

Answered by AI

Do I meet the necessary criteria to participate in this research study?

"To be eligible for participation in this clinical trial, individuals should meet the criteria of having a diagnosis of depression and fall between the ages of 18 and 65. The study aims to recruit approximately 332 suitable candidates."

Answered by AI

Does this medical study have an age inclusion criterion that encompasses individuals who are 70 years of age or older?

"The inclusion criteria for this study specify that eligible participants must be above 18 years of age and below 65 years of age."

Answered by AI

Who else is applying?

What site did they apply to?
Neumora Investigator Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

To help the next generation while helping myself.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder
2023. "Study to Assess the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06058013.
All > Depression Los Angeles > New Orleans
~221 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top