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

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Episode Associated With Bipolar II Disorder

In brief

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.

Key facts

Study ID

NCT06429722

Run by

Neumora Therapeutics, Inc.

People needed

18

Starts

2024-05-13

Expected to finish

2025-05-30

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
• Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Neumora Investigator Site — Phoenix, Arizona, United States
• Neumora Investigator Site — Little Rock, Arkansas, United States
• Neumora Investigator Site — Garden Grove, California, United States
• Neumora Investigator Site — Long Beach, California, United States
• Neumora Investigator Site — San Jose, California, United States
• Neumora Investigator Site — Torrance, California, United States
• Neumora Investigator Site — Gainesville, Florida, United States
• Neumora Investigator Site — Lauderhill, Florida, United States
• Neumora Investigator Site — Maitland, Florida, United States
• Neumora Investigator Site — Miami, Florida, United States
• Neumora Investigator Site — Miami Lakes, Florida, United States
• Neumora Investigator Site — Marietta, Georgia, United States
• Neumora Investigator Site — Savannah, Georgia, United States
• Neumora Investigator Site — Watertown, Massachusetts, United States
• Neumora Investigator Site — Flowood, Mississippi, United States
• Neumora Investigator Site — Marlton, New Jersey, United States
• Neumora Investigator Site — Princeton, New Jersey, United States
• Neumora Investigator Site — Toms River, New Jersey, United States
• Neumora Investigator Site — Brooklyn, New York, United States
• Neumora Investigator Site — Houston, Texas, United States
• Neumora Investigator Site — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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