Can a new drug calm the storm of bipolar mania?

NCT ID NCT06462612

Completed Disease control Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

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.

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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

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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
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Miami Lakes, Florida, 33014, United States
Clinical Site

Miami Lakes, Florida, 33016, United States
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Tampa, Florida, 33629, United States
Clinical Site

West Palm Beach, Florida, 33407, United States
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Atlanta, Georgia, 30331, United States
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Stockbridge, Georgia, 30281, United States
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Chicago, Illinois, 60640, United States
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Chicago, Illinois, 60641, United States
Clinical Site

Gaithersburg, Maryland, 20877, United States
Clinical Site

Glen Oaks, New York, 11004, United States
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Cincinnati, Ohio, 45219, United States
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Richardson, Texas, 75080, United States
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Burgas, 8000, Bulgaria
Clinical Site

Kazanlak, 6100, Bulgaria
Clinical Site

Plovdiv, 4002, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1431, Bulgaria
Clinical Site

Brasov, 507190, Romania
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Bucharest, 06022, Romania
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Iași, 700282, Romania
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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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