Can a dissolving film tame agitation in schizophrenia?

NCT ID NCT04010305

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

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial tests whether a dissolvable film placed under the tongue, containing the drug dexmedetomidine (BXCL501), can reduce agitation in people with schizophrenia. Participants are adults aged 18 to 65 who are clinically agitated. The study compares different doses of the film against a placebo to see which dose works best and is safest.

What this could mean

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

Active substance: A sublingual film containing dexmedetomidine (BXCL501)
What this could lead to: If it works, this could offer a fast, non-injectable option to calm agitation in schizophrenia, potentially improving patient comfort and care.
What could go wrong: This is an early-phase trial, so the drug may not prove effective or safe. Possible side effects include sedation and low blood pressure.

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

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Conditions

The condition(s) this trial relates to.

Psychomotor Agitation schizoaffective disorder schizophrenia schizophreniform disorder

As listed by the trial registrant

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

AGITATION SCHIZOPHRENIA

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

Lemon Grove, California, 91945, 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

Atlanta, Georgia, 30331, United States
BioXcel Clinical Research Site

Gaithersburg, Maryland, 20877, United States
BioXcel Clinical Research Site

Flowood, Mississippi, 39232, United States
BioXcel Clinical Research Site

Berlin, New Jersey, 08009, United States
BioXcel Clinical Research Site

Austin, Texas, 78754, United States
BioXcel Clinical Research Site

Richardson, Texas, 75080, United States

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