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New quick-dissolve film may tame bipolar agitation in minutes

NCT ID NCT04276883

Completed Symptom relief Sponsor: BioXcel Therapeutics Inc Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This study tested a fast-dissolving film (BXCL501) placed under the tongue to quickly reduce agitation in people with bipolar disorder. About 380 adults with bipolar I or II who were very agitated took part. The goal was to see if the film safely calms agitation better than a placebo.

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Conditions

The condition(s) this trial relates to.

bipolar disorder bipolar I disorder bipolar II disorder Psychomotor Agitation

As listed by the trial registrant

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

AGITATION ASSOCIATED WITH BIPOLAR DISORDER AGITATION,PSYCHOMOTOR BIPOLAR DISORDER

Contacts and locations

Locations

  • BioXcel Clinical Research Site

    Little Rock, Arkansas, 72211, United States

  • BioXcel Clinical Research Site

    Cerritos, California, 90703, United States

  • BioXcel Clinical Research Site

    Culver City, California, 90230, United States

  • BioXcel Clinical Research Site

    Long Beach, California, 90806, United States

  • BioXcel Clinical Research Site

    Orange, California, 92868, United States

  • BioXcel Clinical Research Site

    Miami Lakes, Florida, 33016, United States

  • BioXcel Clinical Research Site

    Chicago, Illinois, 60640, United States

  • BioXcel Clinical Research Site

    Gaithersburg, Maryland, 20877, United States

  • BioXcel Clinical Research Site

    Las Vegas, Nevada, 89102, United States

  • BioXcel Clinical Research Site

    Berlin, New Jersey, 08009, United States

  • BioXcel Clinical Research Site

    Marlton, New Jersey, 08053, United States

  • BioXcel Clinical Research Site

    Charleston, South Carolina, 29407, United States

  • BioXcel Clinical Research Site

    Austin, Texas, 78754, United States

  • BioXcel Clinical Research Site

    DeSoto, Texas, 75115, United States

  • BioXcel Clinical Research Site

    Richardson, Texas, 75080, United States

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