Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
← catalyst calendarSponsored by BioXcel Therapeutics Inc (industry) · BTAI — their whole pipeline →. With Premier Research.
Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
33actual
Sites
5
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-19 | actual | When the study began enrolling |
| Primary completion | 2025-10-07 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-07 | actual | The whole study's end, after follow-up |
| First posted | 2025-08-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Bipolar I Disorder
- Bipolar II Disorder
- Schizophrenia
- Schizoaffective Disorder
- Schizophreniform Disorders
- Psychomotor Agitation
Intervention
- Drug: BXCL501 Sublingual Film — also filed as Dexmedetomidine
Primary outcomes
what the primary-completion date above is the date OFInformant and Clinician ratings comparison
measured Before and 2 hours after the intervention
Informant training materials assessment
measured Within 7 days of the intervention
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