NCT07116694Phase 2Completed

Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2025-10-07Actual

Enrollment · participants33Actual

Source updated2026-08-06Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2026-04-06 · 5 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~30 participants (planned)~~

+ After

33 participants (actual)

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Oct 2025~~

+ After

7 Oct 2025

Recruitment status changed

− Before

~~Active not recruiting~~

+ After

Completed

Check registry source

Study details

Conditions studied

Bipolar I Disorder; Bipolar II Disorder; Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders; Psychomotor Agitation

Treatments or interventions studied

BXCL501 Sublingual FilmDrugAlso known as Dexmedetomidine

Primary outcomes · main study measures

Read the study measures

measure: Informant and Clinician ratings comparison; description: The aim of the study is to assess the agreement/correlations among different measures so the comment is correct that different units of measure are being assessed. The informant-completed questionnaire (modified clinical global impression of severity for informants (mCGI-S-INF) and the clinical-rater completed questionnaire, Positive and Negative Syndrome Scale - Excited Component (PEC) are the primary outcomes being assessed. The mCGI-S-INF is a single item with a 0 to 3 point scale with higher values indicating more severe agitation. The PEC is a five item questionnaire with 7-point response options, overall scores range from 5 to 35 with higher scores indicating more severe agitation.; timeFrame: Before and 2 hours after the intervention; measure: Informant training materials assessment; description: Assess content validity of the Modified Clinical Global Impression of Severity for Informants (mCGI-S-INF) and informant training materials. The scale being utilized is mCGI-S-INF. There is no score as it is a qualitative assessment and it is being validated to measure patient informant reported outcomes against patient reported outcomes (mCGI-S-PAT) and physician reported outcomes using the Positive and Negative Syndrome Scale - Excited Component (PEC) scale where the highest score indicates the maximum agitation that could be experienced.; timeFrame: Within 7 days of the intervention

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history