Your session is about to expire
← Back to Search
Other
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
Have you been diagnosed with Major Depressive Disorder?
Be older than 18 years old
Must not have
Have you been diagnosed with bipolar disorder, schizophrenia, OCD, or PTSD?
Do you struggle with substance or alcohol abuse?
Timeline
Screening 3 weeks
Treatment 6 weeks
Follow Up baseline and up to week 6
Awards & highlights
Summary
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.
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.
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.
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 belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ 6 weeks8 visits
Follow Up ~ baseline and up to week 6
Screening ~ 3 weeks
Treatment ~ 6 weeks
Follow Up ~baseline and up to week 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score
Secondary study objectives
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
6 Previous Clinical Trials
1,674 Total Patients Enrolled
5 Trials studying Depression
1,578 Patients Enrolled for Depression
Share this study with friends
Copy Link
Messenger