Can a new drug calm the storm of bipolar mania?

NCT ID NCT06462586

Completed Symptom relief 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 people hospitalized with bipolar I disorder. Participants will receive either lumateperone or a placebo daily for several weeks, and researchers will measure changes in mania severity using a standard rating scale. The goal is to see if lumateperone offers a new option for quickly controlling manic episodes, with or without psychotic features.

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 successful, lumateperone could offer a new treatment option for acute manic episodes in bipolar I disorder, potentially with fewer side effects than current therapies.
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, dry mouth, and dizziness.

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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

Rogers, Arkansas, 72758, United States
Clinical Site

Bellflower, California, 90706, United States
Clinical Site

Culver City, California, 90230, United States
Clinical Site

Garden Grove, California, 92845, United States
Clinical Site

Lemon Grove, California, 91945, United States
Clinical Site

Montclair, California, 91763, United States
Clinical Site

Hallandale, Florida, 33009, United States
Clinical Site

Hialeah, Florida, 33016, United States
Clinical Site

Miami, Florida, 33184, United States
Clinical Site

Miami Gardens, Florida, 33056, United States
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Miami Lakes, Florida, 33016, United States
Clinical Site

Miami Springs, Florida, 33166, United States
Clinical Site

Orlando, Florida, 32807, United States
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Atlanta, Georgia, 30324, United States
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Atlanta, Georgia, 30338, United States
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Decatur, Georgia, 30030, United States
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Savannah, Georgia, 31405, United States
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Shreveport, Louisiana, 71101, United States
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Marlton, New Jersey, 08053, United States
Clinical Site

North Canton, Ohio, 44720, United States
Clinical Site

Austin, Texas, 78701, United States
Clinical Site

Austin, Texas, 78754, United States
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DeSoto, Texas, 75115, United States
Clinical Site

Lovech, 5500, Bulgaria
Clinical Site

Rousse, Bulgaria
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Sofia, 1377, Bulgaria
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Stara Zagora, 6000, Bulgaria
Clinical Site

Veliko Tarnovo, 5000, Bulgaria
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Vratsa, 3000, Bulgaria
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Split, 21000, Croatia
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Zagreb, 10000, Croatia
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Zagreb, 10090, Croatia
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Guwahati, Assam, 781032, India
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Mangalore, Karnataka, 575018, India
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Mysore, Karnataka, 570001, India
Clinical Site

Nashik, Maharashtra, 422005, India
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Ludhiana, Punjab, 141001, India
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Belgrade, 11000, Serbia
Clinical Site

Kovin, 26220, Serbia
Clinical Site

Kragujevac, 34000, Serbia
Clinical Site

Novi Kneževac, 23330, Serbia
Clinical Site

Novi Sad, 21000, Serbia

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