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New pill hopes to lift bipolar II depression

NCT ID NCT06429722

Symptom relief Sponsor: Neumora Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an oral drug called NMRA-335140 (navacaprant) against a placebo in 18 adults with bipolar II disorder who were currently experiencing a major depressive episode. Over 6 weeks, researchers measured changes in depression symptoms using a standard rating scale. The goal was to see if the drug could safely ease depression in this specific group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NMRA-335140 (also called navacaprant)
What this could lead to
If successful, this could point toward a new oral treatment for depressive episodes in bipolar II disorder.
What could go wrong
This is a very small pilot study with only 18 participants, so results may not apply broadly. The drug may not outperform placebo, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

18 people

The number who actually took part.

Started

May 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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). 2. Participant's current MDE and lifetime history of hypomanic episodes must be confirmed by independent assessment. 3. 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. 4. Have a MADRS total score of 25 or higher at Screening and Baseline. 5. A change in MADRS total score between Screening and Baseline of ≤20%. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening (excluding nicotine). 5. 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.

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Conditions

The condition(s) this trial relates to.

bipolar disorder bipolar II disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive episode associated with bipolar ii disorder

Contacts and locations

Locations

  • Neumora Investigator Site

    Phoenix, Arizona, 85012, United States

  • Neumora Investigator Site

    Little Rock, Arkansas, 72211, United States

  • Neumora Investigator Site

    Garden Grove, California, 92845, United States

  • Neumora Investigator Site

    Long Beach, California, 90807, United States

  • Neumora Investigator Site

    San Jose, California, 95124, United States

  • Neumora Investigator Site

    Torrance, California, 90504, United States

  • Neumora Investigator Site

    Gainesville, Florida, 32607, United States

  • Neumora Investigator Site

    Lauderhill, Florida, 33161, United States

  • Neumora Investigator Site

    Maitland, Florida, 32751, United States

  • Neumora Investigator Site

    Miami, Florida, 33122, United States

  • Neumora Investigator Site

    Miami Lakes, Florida, 33016, United States

  • Neumora Investigator Site

    Marietta, Georgia, 30060, United States

  • Neumora Investigator Site

    Savannah, Georgia, 31405, United States

  • Neumora Investigator Site

    Watertown, Massachusetts, 02472, United States

  • Neumora Investigator Site

    Flowood, Mississippi, 39232, United States

  • Neumora Investigator Site

    Marlton, New Jersey, 08053, United States

  • Neumora Investigator Site

    Princeton, New Jersey, 08540, United States

  • Neumora Investigator Site

    Toms River, New Jersey, 08755, United States

  • Neumora Investigator Site

    Brooklyn, New York, 11229, United States

  • Neumora Investigator Site

    Houston, Texas, 77030, United States

  • Neumora Investigator Site

    Bellevue, Washington, 98007, United States