NCT07116694

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: BioXcel Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with Bipolar Disorders, Schizophrenia, Schizoaffective, and Schizophreniform disorders and correlate them with clinician-assessed ratings.

Detailed description

This is an open-label study to assess acute psychomotor agitation measures in patient-informant dyads with adult (18-75 years old) males and females experiencing an agitation episode associated with bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder. This validation study will include collecting data from approximately 30 patient-informant dyads during and following an acute psychomotor agitation episode. Data will be collected during the episodes from the dyads and the clinical rater for up to two hours after baseline. The aim of the informant, patient, and investigator ratings will be to assess rater agreement between investigators and informants, as well as investigators and patients.

Conditions

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

Interventions

Type	Name	Description
DRUG	BXCL501 Sublingual Film	Single dose BXCL501 120 mcg

Timeline

• Start date: 2025-06-19
• Primary completion: 2025-10-07
• Completion: 2025-10-07
• First posted: 2025-08-11
• Last updated: 2026-04-06

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study