Study to Assess the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder

Phase 3

Recruiting

• Conditions: Major Depressive Disorder
• Interventions: Drug: NMRA-335140; Drug: Placebo

• Registration Number: NCT06058013
• Lead Sponsor: Neumora Therapeutics, Inc.

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicenter 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 open-label extension study (NMRA-335140-501).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Study Start: 2023-12-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-01
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMRA-335140 80 milligrams (mg) once daily (QD)	NMRA-335140	Participants will receive a NMRA- 335140 tablet at a dose of 80 mg once daily (QD)
Placebo	Placebo	Placebo participants will receive matching placebo tablet once daily.

Primary Outcome Measures

Name	Time	Method
Change from Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score	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 Outcome Measures

Name	Time	Method
Change from Baseline to Week 6 assessed in the Snaith-Hamilton Pleasure Scale (SHAPS) total score	Baseline and up to Week 6	The SHAPS is a 14-item participant-reported instrument which measures anhedonia. It has been shown to be valid and reliable in normal and clinical samples, with adequate construct validity, satisfactory test-retest reliability and high internal consistency. The scale will be completed by the participant and reviewed by site personnel qualified to oversee completeness. Each of the 14 items has a set of 4 responses, 2 of which endorse agreement (Definitely Agree, Agree) and 2 of which endorse disagreement (Disagree, Strongly Disagree). A total score can be derived by summing the response items, where those answered with "strongly agree" will be coded as a 1, while a "strongly disagree" response will be coded as 4. Therefore, scores on the SHAPS can range from 14 to 56, with higher scores corresponding to higher levels of anhedonia.

Trial Locations

Locations (5)

Neumora Investigator Site -2; 🇺🇸 Tampa, Florida, United States

Neumora Investigator Site-1; 🇺🇸 Tampa, Florida, United States

Neumora Investigator Site; 🇨🇱 Antofagasta, Chile

Neumora Investigator site; 🇨🇦 Markham, Ontario, Canada

Neumora Investigator Site #1; 🇺🇸 New York, New York, United States