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
Overview
- Phase
- Phase 3
- Intervention
- NMRA-335140
- Conditions
- Major Depressive Disorder
- Sponsor
- Neumora Therapeutics, Inc.
- Enrollment
- 383
- Locations
- 3
- Primary Endpoint
- Change from Baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
This is a randomized, double blind, placebo controlled, multi-center study to 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 28 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 extension study (NMRA 335140 501).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
NMRA-335140 80 milligrams (mg) once daily (QD)
Participants will receive a NMRA-335140 tablet at a dose of 80 mg once daily (QD)
Intervention: NMRA-335140
Placebo
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Change from Baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score
Time Frame: Baseline and up to Week 6
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 to 60, with increasing scores indicating increasing severity.
Secondary Outcomes
- Change from Baseline to Week 6 assessed in the Snaith-Hamilton Pleasure Scale (SHAPS) total score(Baseline and up to Week 6)