To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar II Disorder.

NCT06429722 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: NMRA-335140-202
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 21

Brief Summary

This is a randomized, double-blind, placebo-controlled pilot study aiming to evaluate the effects of NMRA-335140 on symptoms of major depression in adults with Bipolar (BP) II disorder. The study design consists of a Screening Period (up to 28 days), a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo), and a 6-week Safety Follow-up Period.

Conditions

Major Depressive Episode Associated With Bipolar II Disorder

Keywords

NMRA-335140; Navacaprant; BTRX-335140; CYM-53093; Bipolar II Disorder; Major Depressive Episode; Placebo-controlled; Double-blind; NMRA335140; NMRA 335140

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and up to Week 6

Secondary Outcomes (1)

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

  Baseline and up to Week 6

Study Arms (2)

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

EXPERIMENTAL

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

Drug: NMRA-335140 80 mg

Placebo

PLACEBO COMPARATOR

Placebo participants will receive matching placebo tablet once daily.

Drug: Placebo

Interventions

Placebo DRUG

Placebo will be administered orally

Placebo

NMRA-335140 80 mg DRUG

Participants will receive NMRA-335140 at a dose of 80 mg QD, orally.

Also known as: BTRX-335140, CYM-53093, Navacaprant

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of BP II disorder with a current major depressive episode (MDE), 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 MDE and lifetime history of hypomanic episodes must be confirmed by independent assessment.
• The symptoms of the current MDE 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%.

You may not qualify if:

• Have failed 2 or more courses of antidepressant (adequate dose and duration, i.e., minimum 6 weeks) or mood stabilizer/antipsychotic treatment (each or in combination) for treatment of depressive symptoms in the current MDE.
• Have currently or in the past year any of the following DSM-5-TR disorders: bipolar episodes with mixed features (including the current MDE), bipolar II with rapid cycling pattern (4 or more distinct mood episodes during a 12-month period). Participants with comorbid generalized anxiety disorder, social anxiety disorder, simple phobias, panic disorder, for whom bipolar II MDE is considered the primary diagnosis are not excluded.
• Have a lifetime diagnosis of bipolar I disorder (manic episode schizophrenia, schizoaffective disorder, schizophreniform disorder, anorexia nervosa, bulimia nervosa, cluster B personality disorder, post-traumatic stress disorder (PTSD), or obsessive- compulsive disorder.
• 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 (e.g., 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 ideation 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.

Sponsors & Collaborators

• Neumora Therapeutics, Inc.: lead

Study Sites (21)

Neumora Investigator Site

Phoenix, Arizona, 85012, United States

Location

Neumora Investigator Site

Little Rock, Arkansas, 72211, United States

Location

Neumora Investigator Site

Garden Grove, California, 92845, United States

Location

Neumora Investigator Site

Long Beach, California, 90807, United States

Location

Neumora Investigator Site

San Jose, California, 95124, United States

Location

Neumora Investigator Site

Torrance, California, 90504, United States

Location

Neumora Investigator Site

Gainesville, Florida, 32607, United States

Location

Neumora Investigator Site

Lauderhill, Florida, 33161, United States

Location

Neumora Investigator Site

Maitland, Florida, 32751, United States

Location

Neumora Investigator Site

Miami, Florida, 33122, United States

Location

Neumora Investigator Site

Miami Lakes, Florida, 33016, United States

Location

Neumora Investigator Site

Marietta, Georgia, 30060, United States

Location

Neumora Investigator Site

Savannah, Georgia, 31405, United States

Location

Neumora Investigator Site

Watertown, Massachusetts, 02472, United States

Location

Neumora Investigator Site

Flowood, Mississippi, 39232, United States

Location

Neumora Investigator Site

Marlton, New Jersey, 08053, United States

Location

Neumora Investigator Site

Princeton, New Jersey, 08540, United States

Location

Neumora Investigator Site

Toms River, New Jersey, 08755, United States

Location

Neumora Investigator Site

Brooklyn, New York, 11229, United States

Location

Neumora Investigator Site

Houston, Texas, 77030, United States

Location

Neumora Investigator Site

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

BTRX-335140

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor will also be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: May 13, 2024
• Primary Completion: April 9, 2025
• Study Completion: May 30, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (21)