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Can a new drug calm the storm of bipolar mania?

NCT ID NCT06462612

Disease control Sponsor: Intra-Cellular Therapies, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This phase 3 trial is testing whether the experimental drug lumateperone can safely reduce manic symptoms in adults hospitalized with bipolar I disorder who are currently experiencing a manic or mixed episode. Participants will receive either lumateperone or a placebo daily for several weeks, and researchers will track changes in mania severity using a standard rating scale. The goal is to see if lumateperone offers a new, well-tolerated option for quickly controlling acute mania.

What this could mean

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

Active substance
the drug lumateperone (42 mg capsules taken once daily)
What this could lead to
If effective, lumateperone could offer a new treatment option for acute manic episodes in bipolar I disorder, potentially with fewer side effects than existing medications.
What could go wrong
This is an early-phase trial, so the drug may not prove more effective than placebo. Possible side effects include drowsiness, dizziness, and dry mouth; long-term safety is not yet established.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

351 people

The number who actually took part.

Started

Jul 2024

Finished

May 2026

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 75 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. Able to provide written informed consent before the initiation of any study specific procedures; 2. Male or female inpatient, between the ages of 18 and 75 years, inclusive; 3. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT); 4. YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior at Screening and Baseline; 5. Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not \> 14 days before Screening. Hospital admission must be a result of the current manic episode. Exclusion Criteria: 1. Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include: 1. Schizophrenia, schizoaffective disorder, or other psychotic disorders; 2. Dementia or other cognitive disorders; 3. Intellectual disability; 4. Moderate or severe substance use disorder (excluding for nicotine); 2. Experiencing first manic episode; 3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or 1. At Screening, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening; or 2. At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or 3. At Baseline, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or 4. At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or 5. Considered to be an imminent danger to himself/herself or others.

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Conditions

The condition(s) this trial relates to.

bipolar disorder bipolar I disorder manic bipolar affective disorder

As listed by the trial registrant

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

Bipolar disorder, manic

Contacts and locations

Locations

  • Clinical Site

    Bentonville, Arkansas, 72712, United States

  • Clinical Site

    Little Rock, Arkansas, 72211, United States

  • Clinical Site

    Anaheim, California, 92805, United States

  • Clinical Site

    Cerritos, California, 90703, United States

  • Clinical Site

    Orange, California, 92868, United States

  • Clinical Site

    Torrance, California, 90504, United States

  • Clinical Site

    Hialeah, Florida, 33012, United States

  • Clinical Site

    Miami, Florida, 33122, United States

  • Clinical Site

    Miami, Florida, 33135, United States

  • Clinical Site

    Miami, Florida, 33145, United States

  • Clinical Site

    Miami Lakes, Florida, 33014, United States

  • Clinical Site

    Miami Lakes, Florida, 33016, United States

  • Clinical Site

    Tampa, Florida, 33629, United States

  • Clinical Site

    West Palm Beach, Florida, 33407, United States

  • Clinical Site

    Atlanta, Georgia, 30331, United States

  • Clinical Site

    Stockbridge, Georgia, 30281, United States

  • Clinical Site

    Chicago, Illinois, 60640, United States

  • Clinical Site

    Chicago, Illinois, 60641, United States

  • Clinical Site

    Gaithersburg, Maryland, 20877, United States

  • Clinical Site

    Glen Oaks, New York, 11004, United States

  • Clinical Site

    Cincinnati, Ohio, 45219, United States

  • Clinical Site

    Richardson, Texas, 75080, United States

  • Clinical Site

    Burgas, 8000, Bulgaria

  • Clinical Site

    Kazanlak, 6100, Bulgaria

  • Clinical Site

    Plovdiv, 4002, Bulgaria

  • Clinical Site

    Sliven, 8800, Bulgaria

  • Clinical Site

    Sofia, 1431, Bulgaria

  • Clinical Site

    Brasov, 507190, Romania

  • Clinical Site

    Bucharest, 06022, Romania

  • Clinical Site

    Iași, 700282, Romania

  • Clinical Site

    Belgrade, 11000, Serbia

  • Clinical Site

    Kovin, 26220, Serbia

  • Clinical Site

    Kragujevac, 34000, Serbia

  • Clinical Site

    Niš, Serbia

  • Clinical Site

    Novi Kneževac, Serbia

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