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NCT06058039 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder
A Phase 3 study of Major Depressive Disorder, sponsored by Neumora Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 332
- Enrollment target
- 20
- Study locations
NCT06058039: Recruiting Phase 3 study of Major Depressive Disorder, sponsored by Neumora Therapeutics.
NCT06058039 is a Phase 3 study of Major Depressive Disorder that is actively recruiting participants, run by Neumora Therapeutics. The registered enrollment target is 332 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06058039, a Phase 3 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Neumora Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 332 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of NMRA-335140 (formerly BTRX-335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 35 days), and a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo). At the completion of the 6-week Treatment Period, participants who complete the study, provide informed consent, and meet the eligibility criteria may enter an open-label extension study (NMRA-335140-501).
Primary Outcome
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7- point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. Thus, scores in the MADRS range from 0
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NMRA-335140
Study Locations (20)
Florida
- Neumora Investigator Site - Brandon
- Neumora Investigator Site - Hialeah
- Neumora Investigator Site - Hialeah
- Neumora Investigator Site - Jacksonville
- Neumora Investigator Site - Miami
- Neumora Investigator Site - Miami
- Neumora Investigator site - Miami
- Neumora Investigator Site - Miami Beach
- Neumora Investigator site - Miami Springs
- Neumora Investigator Site - Palm Bay
- Neumora Investigator Site - Pembroke Pines
- Neumora Investigator Site - Pompano Beach
- Neumora Investigator Site - Saint Augustine
California
- Neumora Investigator Site - Cerritos
- Neumora Investigator Site - Irvine
- Neumora Investigator Site - Long Beach
- Neumora Investigator Site - San Diego
- Neumora Investigator Site - San Francisco
Connecticut
- Neumora Investigator Site - New Haven
Georgia
- Neumora Investigator Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 332 participants |
| Start Date | 2023-12-21 |
| Est. Completion | 2026-03 |
| Phase | Phase 3 |
What NCT06058039 shows while recruiting
NCT06058039 is an interventional study that assigns participants to a tested intervention. The registered 332 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (12% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06058039 names 20 study sites across 4 states, led by Florida, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06058039 about?
NCT06058039 is a clinical study titled "Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder". This randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of NMRA-335140 (formerly BTRX-335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 35 days), and a 6-week Treatment...
What is the current status of trial NCT06058039?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 332 participants. The study started on 2023-12-21. Estimated completion is 2026-03.
What conditions does trial NCT06058039 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT06058039?
The interventions under investigation include: Placebo (DRUG), NMRA-335140 (DRUG).
Who is sponsoring clinical trial NCT06058039?
This trial is sponsored by Neumora Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06058039 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06058039's enrollment target sits among peer trials
332 50th of 282 higher than 232 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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