New sublingual film aims to calm agitation at home for mental health patients
NCT ID NCT05658510
First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This study tested an investigational medication called BXCL501 (dexmedetomidine) given as a film under the tongue for episodes of agitation in people with schizophrenia, schizoaffective disorder, or bipolar disorder. The trial included 452 adults aged 18-75 and compared the drug to a placebo in a double-blind design. The goal was to see if BXCL501 could safely and effectively reduce agitation when used at home, without needing to go to a hospital.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Dexmedetomidine (sublingual film)
- What this could lead to
- If successful, this could provide a fast-acting, at-home treatment option for agitation episodes in people with schizophrenia or bipolar disorder, potentially reducing hospital visits.
- What could go wrong
- This is a completed Phase 3 trial, but results are not yet published. The drug may not work better than placebo, and side effects like low blood pressure or drowsiness are possible.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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BioXcel Clinical Research Site 102
DeSoto, Texas, 75115, United States
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BioXcel Clinical Research Site 103
Gaithersburg, Maryland, 20877, United States
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BioXcel Clinical Research Site 104
Orange, California, 92868, United States
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BioXcel Clinical Research Site 105
Berlin, New Jersey, 08009, United States
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BioXcel Clinical Research Site 108
Garden Grove, California, 92845, United States
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BioXcel Clinical Research Site 110
Culver City, California, 90230, United States
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BioXcel Clinical Research Site 113
Bellflower, California, 90706, United States
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BioXcel Clinical Research Site 114
Riverside, California, 92506, United States
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BioXcel Clinical Research Site 117
Lemon Grove, California, 91945, United States
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BioXcel Clinical Research Site 118
Las Vegas, Nevada, 89102, United States
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BioXcel Clinical Research Site 121
Los Angeles, California, 90015, United States
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BioXcel Clinical Research Site 122
Beachwood, Ohio, 44122, United States
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BioXcel Clinical Research Site 123
Oceanside, California, 92056, United States
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BioXcel Clinical Research Site 124
Miami, Florida, 33186, United States
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BioXcel Clinical Research Site 125
Irving, Texas, 75062, United States
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BioXcel Clinical Research Site 126
Everett, Washington, 98201, United States
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BioXcel Clinical Research Site 127
Plano, Texas, 75093, United States
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BioXcel Clinical Research Site 128
Cerritos, California, 90703, United States
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BioXcel Clinical Research Site 129
Denver, Colorado, 80209, United States
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BioXcel Clinical Research Site 130
Elgin, Illinois, 60123, United States
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BioXcel Clinical Research Site 131
Miami, Florida, 33122, United States
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BioXcel Clinical Research Site 133
Rancho Cucamonga, California, 91730, United States
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BioXcel Clinical Research Site 136
Austin, Texas, 78754, United States
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BioXcel Clinical Research Site 137
Las Vegas, Nevada, 89119, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a dissolving film tame agitation in schizophrenia?
- Can a phone app teach the brain to read social cues?
- Can a gentle brain current silence voices that medication Can't?