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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
Participant's current major depressive episode must be confirmed by independent assessment
The symptoms of the current MDD episode have been present for more than 4 weeks prior to the Screening Visit, but no longer than 12 months prior to the Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to week 6
Awards & highlights

Study Summary

This trial tests a drug (NMRA 335140) for symptoms of depression in people with Major Depressive Disorder. It has a screening period, a 6-week treatment period with either the drug or placebo, and an extension study.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally could include typical reactions to new psychiatric medications such as nausea, headaches, sleep disturbances, changes in appetite or weight, fatigue, dizziness, and possibly increased anxiety at the start.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My current depression symptoms have lasted more than 4 weeks but less than 12 months.

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 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 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.

Is it possible for people younger than 85 years old to participate in this scientific investigation?

"This research project requires that all participants are aged 18 to 65 years. For those younger and older than this limit, there are 219 clinical trials for patients under the age of 18 and 1024 for individuals over 65."

Answered by AI

What is the highest number of participants that can take part in this research?

"Affirmative. Clinicaltrials.gov indicates that this medical research, which was first uploaded on September 20th 2023, is actively seeking participants. The trial requires 332 patients to be recruited from 3 distinct medical centres."

Answered by AI

Has the FDA approved a dosage of 80 milligrams (mg) administered on a daily basis for NMRA-335140?

"Our team assigned a score of 3 to NMRA-335140 80 milligrams (mg) administered once daily (QD), as there is existing clinical data that confirms the medication's safety and efficacy."

Answered by AI

Is the enrollment process for this experiment still open?

"Affirmative. According to clinicaltrials.gov, this medical trial which debuted on September 20th of 2023 is enrolling patients right now. 332 people are needed from 3 different healthcare centres."

Answered by AI

Does my profile qualify me to join this research project?

"For admittance to this clinical trial, 332 depressed individuals aged 18-65 must meet a set of stringent criteria. These involve recording no more than 20% change in MADRS total score between Screening and Baseline; obtaining a primary DSM-5-TR diagnosis for MDD without psychotic features through SCID 5 CT at screening (which may be either their first or recurrent episode); confirming the major depressive episode independent assessment; having had symptoms for over 4 weeks but no longer than 12 months prior to the Screening Visit; and finally presenting with a minimum MADRS total score of 25 during both visits."

Answered by AI

Who else is applying?

What site did they apply to?
Segal Trials - Lauderhill, FL
Neumora Investigator Site
Segal Trials - Miami Lakes, FL
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

It appears I'm a fit for this study. I am still struggling with depression and I'm hoping this can help.
PatientReceived no prior treatments
I want to feel better already I have tried other medications and I don't feel any better, I'm hopeful for this medication.
PatientReceived no prior treatments
Long-term MDD condition; many anti-depressants tried; all worked for a limited amount of time; it now seems like standard Serotonin/Dopamine/Norepinephrine formulas are insufficiently effective, as high level of depression remain.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long is screening?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Segal Trials - Lauderhill, FL: < 24 hours
  2. Segal Trials - Miami Lakes, FL: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Effects of Oral NMRA 335140 Versus Placebo in Participants With Major Depressive Disorder
2023. "Study to Evaluate the Effects of Oral NMRA 335140 Versus Placebo in Participants With Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06029426.
All > Depression Los Angeles > Paid Studies Las Vegas
~166 spots leftby Dec 2024
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