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

NCT07116694 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BXCL501 Sublingual Film

Single dose BXCL501 120 mcg

Sponsors & Collaborators

  • Premier Research

    collaborator OTHER

  • BioXcel Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Matt Mandel, MD · BioXcel Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-19
Primary Completion
2025-10-07
Completion
2025-10-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07116694 on ClinicalTrials.gov