A Phase 3, Randomized, Double blind, Placebo controlled Study to Evaluate the Effects of Oral NMRA-335140 versus Placebo in Participants with Major Depressive Disorder

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506335-15-00

Acronym

NMRA-335140-303

Enrollment

127

Registered

2024-06-20

Start date

2024-07-18

Completion date

Unknown

Last updated

2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Brief summary

The primary endpoint is the treatment difference in change from Baseline to Week 6 in the MADRS total score.

Detailed description

The secondary endpoint is the change from Baseline to Week 6 assessed in the SHAPS total score.

Interventions

DRUGPlacebo is identical to the active NMRA-335140 but without the active drug substance to maintain study blinding.

DRUGNMRA-335140

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the treatment difference in change from Baseline to Week 6 in the MADRS total score.	—

Secondary

Measure	Time frame
The secondary endpoint is the change from Baseline to Week 6 assessed in the SHAPS total score.	—

Countries

Bulgaria, Czechia, Finland, France, Germany, Poland, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026