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

Not Applicable

Recruiting

• Conditions: Bipolar I Disorder; Schizophrenia; Bipolar II Disorder; Schizophreniform Disorders; Psychomotor Agitation; Schizoaffective Disorder
• Interventions: Drug: BXCL501 Sublingual Film

• Registration Number: NCT07116694
• Lead Sponsor: BioXcel Therapeutics Inc

Brief 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.

Study Timeline

• Study Start: 2025-06-19
• Study First Submitted: 2025-07-07
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BXCL501 Sublingual film	BXCL501 Sublingual Film	Experimental: 120 mcg of BXCL501 Sublingual film containing 120 Micrograms Dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Informant and Clinician ratings comparison	Before and 2 hours after the intervention	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.
Informant training materials assessment	Within 7 days of the intervention	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.

Secondary Outcome Measures

Name	Time	Method
Patient and Clinician ratings comparison	Before and 2 hours after the intervention	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 patient-completed questionnaire (modified clinical global impression of severity for patients (mCGI-S-P) and the clinical-rater completed questionnaire, Positive and Negative Syndrome Scale - Excited Component (PEC) are the primary outcomes being assessed. The mCGI-S-P 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.
Patient training materials assessment	Within 7 days of the intervention	Assess content validity of the Modified Clinical Global Impression of Severity for Patients (mCGI-S-PAT) training materials. The scale being utilized is mCGI-S-PAT. There is no score as it is a qualitative assessment and is being validated to measure patient reported outcomes against 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.
Patients completion of the Modified Clinical Global Impression of Severity for Patients (mCGI-S-PAT)	Before and 2 hours after the intervention	Evaluate whether patients with acute psychomotor agitation can complete the Modified Clinical Global Impression of Severity for Patients (mCGI-S-PAT) evaluation tool. The mCGI-S-PAT is already in the trial protocol and this protocol so it would be disruptive to rename the item at this point. The measure assesses severity of agitation 'right now' with response options of none, mild, moderate, and severe.

Trial Locations

Locations (5)

BioXcel Clinical Research Site 103; 🇺🇸 Chino, California, United States

BioXcel Clinical Research Site 105; 🇺🇸 Oceanside, California, United States

BioXcel Clinical Research Site 102; 🇺🇸 Orange, California, United States

BioXcel Clinical Research Site 101; 🇺🇸 Saint Louis, Missouri, United States

BioXcel Clinical Research Site 106; 🇺🇸 Las Vegas, Nevada, United States