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Could a dissolving film calm agitated teens? new trial begins

NCT ID NCT05025605

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

First seen Jun 24, 2026 · Last updated Aug 12, 2026 · Updated 4 times

Summary

This early-stage trial tests BXCL501, a dissolving film placed under the tongue, to quickly reduce agitation in children and teens aged 10-17 with schizophrenia or bipolar disorder. About 140 participants will receive either the drug or a placebo. The study measures changes in agitation using a standard psychiatric scale.

What this could mean

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

Active substance
BXCL501 (dexmedetomidine sublingual film)
What this could lead to
If it works, this could offer a fast-acting, non-injectable option to calm agitation in children and teens with these conditions.
What could go wrong
This is a very early phase 1 study with only 140 participants, so results may not apply broadly. Side effects of dexmedetomidine include low blood pressure and drowsiness.

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.

bipolar disorder bipolar I disorder bipolar II disorder Psychotic Disorders schizoaffective disorder schizophrenia schizophreniform disorder

As listed by the trial registrant

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

BIPOLAR DISORDER I BIPOLAR DISORDER II SCHIZO AFFECTIVE DISORDER SCHIZOPHRENIA SCHIZOPHRENIFORM; SCHIZOPHRENIC

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • BioXcel Clinical Research Site

    RECRUITING

    Anaheim, California, 92805, United States

    Contact Email: •••••@•••••

  • BioXcel Clinical Research Site

    COMPLETED

    Atlanta, Georgia, 30331, United States

  • BioXcel Clinical Research Site

    RECRUITING

    DeSoto, Texas, 75115, United States

    Contact Email: •••••@•••••

  • Bioxcel Clinical Research Site

    RECRUITING

    Hialeah, Florida, 33016, United States

    Contact Email: •••••@•••••

  • Bioxcel Clinical Research Site

    RECRUITING

    Decatur, Georgia, 30030, United States

    Contact Email: •••••@•••••

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