Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
452actual
Sites
24
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 | 2022-11-21 | actual | When the study began enrolling |
| Primary completion | 2025-08-15 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-08-15 | actual | The whole study's end, after follow-up |
| First posted | 2022-12-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Agitation,Psychomotor
- Bipolar I Disorder
- Bipolar II Disorder
- Schizophrenia
- Schizoaffective Disorder
- Schizophreniform Disorders
Interventions
- Drug: BXCL501 — also filed as Dexmedetomidine
- Drug: Matching Placebo — also filed as Placebo
Primary outcomes
what the primary-completion date above is the date OFPart 1: Change from baseline in Positive and Negative Syndrome Scale - Excited (PEC) total score
measured 2 hours
Part 2: The incidence of SAEs and TEAEs compared with placebo.
measured Through study completion, an average of 12 weeks
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