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

Primary Purpose

Major Depressive Disorder

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
NMRA-335140
Placebo
Sponsored by
Neumora Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, NMRA-335140, Placebo-controlled, Double-blind, Navacaprant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of MDD without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID 5 CT) at screening (this may be a first or recurrent episode). Participant's current major depressive episode must be confirmed by independent assessment. The symptoms of the current MDD episode have been present for more than 4 weeks prior to the Screening Visit, but no longer than 12 months prior to the Screening Visit. Have a MADRS total score of 25 or higher at Screening and Baseline. A change in MADRS total score between Screening and Baseline of ≤20%. Key Exclusion Criteria: Have failed 2 or more courses of antidepressant treatment for the current MDD episode. Have currently or in the past year any of the following DSM-5-TR disorders: personality disorder, anorexia nervosa, bulimia nervosa, or binge eating disorder. Participants with comorbid generalized anxiety disorder, social anxiety disorder, simple phobias, or panic disorder for whom MDD is considered the primary diagnosis are not excluded. Have a lifetime diagnosis of bipolar 1 or 2, schizophrenia, obsessive compulsive disorder, or post-traumatic stress disorder (PTSD). Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening (excluding nicotine). Are actively suicidal (eg, any suicide attempts within the past 12 months) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) (score of "YES" on suicidal ideations Item 4 or 5 within 3 months prior to Visit 1 [Screening]) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    NMRA-335140 80 milligrams (mg) once daily (QD)

    Placebo

    Arm Description

    Participants will receive a NMRA-335140 tablet at a dose of 80 mg QD

    Placebo participants will receive matching placebo tablet once daily

    Outcomes

    Primary Outcome Measures

    Change from Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
    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

    Change from Baseline to Week 6 assessed in the Snaith-Hamilton Pleasure Scale (SHAPS) total score
    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.

    Full Information

    First Posted
    September 21, 2023
    Last Updated
    September 21, 2023
    Sponsor
    Neumora Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06058039
    Brief Title
    Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Neumora Therapeutics, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder
    Keywords
    Major Depressive Disorder, NMRA-335140, Placebo-controlled, Double-blind, Navacaprant

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Sponsor will also be blinded
    Allocation
    Randomized
    Enrollment
    332 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NMRA-335140 80 milligrams (mg) once daily (QD)
    Arm Type
    Experimental
    Arm Description
    Participants will receive a NMRA-335140 tablet at a dose of 80 mg QD
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo participants will receive matching placebo tablet once daily
    Intervention Type
    Drug
    Intervention Name(s)
    NMRA-335140
    Other Intervention Name(s)
    BTRX-335140, CYM-53093, Navacaprant
    Intervention Description
    Participants will receive NMRA-335140 at a dose of 80 mg QD, orally
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo will be administered orally
    Primary Outcome Measure Information:
    Title
    Change from Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
    Description
    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.
    Time Frame
    Baseline and up to Week 6
    Secondary Outcome Measure Information:
    Title
    Change from Baseline to Week 6 assessed in the Snaith-Hamilton Pleasure Scale (SHAPS) total score
    Description
    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.
    Time Frame
    Baseline and up to Week 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of MDD without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID 5 CT) at screening (this may be a first or recurrent episode). Participant's current major depressive episode must be confirmed by independent assessment. The symptoms of the current MDD episode have been present for more than 4 weeks prior to the Screening Visit, but no longer than 12 months prior to the Screening Visit. Have a MADRS total score of 25 or higher at Screening and Baseline. A change in MADRS total score between Screening and Baseline of ≤20%. Key Exclusion Criteria: Have failed 2 or more courses of antidepressant treatment for the current MDD episode. Have currently or in the past year any of the following DSM-5-TR disorders: personality disorder, anorexia nervosa, bulimia nervosa, or binge eating disorder. Participants with comorbid generalized anxiety disorder, social anxiety disorder, simple phobias, or panic disorder for whom MDD is considered the primary diagnosis are not excluded. Have a lifetime diagnosis of bipolar 1 or 2, schizophrenia, obsessive compulsive disorder, or post-traumatic stress disorder (PTSD). Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening (excluding nicotine). Are actively suicidal (eg, any suicide attempts within the past 12 months) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) (score of "YES" on suicidal ideations Item 4 or 5 within 3 months prior to Visit 1 [Screening]) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Study Contact
    Email
    Clinicaltrials@neumoratx.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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