Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
← catalyst calendarNCT05025605 · readout in 345 d
Sponsored by BioXcel Therapeutics Inc (industry) · BTAI — their whole pipeline →. With ProPharma Group.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
140estimated
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 | 2021-08-27 | actual | When the study began enrolling |
| Primary completion | 2027-07-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2021-08-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Schizophrenia
- Schizo-Affective Disorder
- Schizophreniform; Schizophrenic
- Bipolar Disorder I
- Bipolar Disorder II
Interventions
- Drug: BXCL501 80 Micrograms — also filed as Dexmedetomidine
- Drug: Placebo Film — also filed as Placebo
- Drug: BXCL501 120 Micrograms — also filed as Dexmedetomidine
- Drug: BXCL501 60 Micrograms — also filed as Dexmedetomidine
Primary outcome
what the primary-completion date above is the date OFAbsolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score
measured 120 minutes - Group one only
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