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NMRA-335140 80 milligrams (mg) once daily (QD) for Depression

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
Key
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to week 6
Awards & highlights

Study Summary

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

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.Check my eligibility
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.See study design
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
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It seems like this criterion is incomplete. Can you please provide more context or details so that I can assist you accurately?
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I have been diagnosed with major depression without psychosis.

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 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.

Is this clinical trial actively seeking participants at the moment?

"Indeed, as per the information provided on clinicaltrials.gov, this trial is currently seeking individuals to participate. The study was initially posted on December 21st, 2023 and was most recently updated on December 27th, 2023. The trial aims to enroll a total of 332 participants at one designated site."

Answered by AI

What is the level of safety associated with NMRA-335140 at a dosage of 80 milligrams (mg) administered once daily (QD) for individuals?

"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

What is the upper limit in terms of patient enrollment for this medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking eligible participants. The initial posting of the trial was made on December 21st, 2023 and it was last updated on December 27th, 2023. The study aims to enroll a total of 332 individuals from a single designated location."

Answered by AI

Are individuals who are above the age of 50 eligible to participate in this medical study?

"To be eligible for participation in this clinical trial, patients must fall within the age range of 18 to 65. It is worth noting that there are a total of 211 studies available specifically for individuals under the age of 18 and an additional 977 studies catering to patients over the age of 65."

Answered by AI

Who else is applying?

What site did they apply to?
Neumora Investigator Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder
2023. "Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06058039.
All > Depression Baltimore
~221 spots leftby Mar 2025
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