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

NCT07116694 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: BXCL501-402
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Informant and Clinician ratings comparison

  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.

  Before and 2 hours after the intervention

• Informant training materials assessment

  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.

  Within 7 days of the intervention

Secondary Outcomes (3)

• Patient and Clinician ratings comparison

  Before and 2 hours after the intervention

• Patient training materials assessment

  Within 7 days of the intervention

• Patients completion of the Modified Clinical Global Impression of Severity for Patients (mCGI-S-PAT)

  Before and 2 hours after the intervention

Study Arms (1)

BXCL501 Sublingual film

EXPERIMENTAL

Experimental: 120 mcg of BXCL501 Sublingual film containing 120 Micrograms Dexmedetomidine

Drug: BXCL501 Sublingual Film

Interventions

BXCL501 Sublingual Film DRUG

Single dose BXCL501 120 mcg

Also known as: Dexmedetomidine

BXCL501 Sublingual film

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 18 to 75 years old, inclusive.
• Patients who can read, understand, and provide written informed consent.
• Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, v5, Text Revision (DSM-5-TR) criteria for a primary diagnosis of bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder.
• Patients who, in the opinion of the principal investigator, are in good general health prior to study participation as determined by a detailed medical history, a physical examination, and a 12-lead electrocardiogram (ECG).
• Female participants, if of child-bearing potential and sexually active, and male participants, if sexually active with a partner of child-bearing potential, agree to use a medically acceptable and effective birth control method throughout the study and for one month following the end of the study.
• Based on history, in the past 30 days prior to Screening, patients must have had at least one clinical presentation of agitation requiring intervention.
• Patients who are receiving stable psychotropic treatment for 30 days prior to Screening for the underlying primary diagnosis and who are expected to remain on stable treatment for the duration of the study.
• At least 18 years of age at the time of screening.
• Is a spouse, significant other, family member, friend, home health aide, or residence manager of an adult patient who:
• Has a clinical diagnosis of bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder.

You may not qualify if:

• Has known the patient for at least 12 months cumulatively.
• Currently living with or routinely contacting the patient at least five days a week.
• Does not plan to discontinue contact with the patient during the study period.
• Willing and able to provide written informed consent.
• Patients with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, or hematologic disease.
• The investigator believes the patient has a history of agitation episodes due to substance use.
• A diagnosis of antisocial personality disorder, borderline personality disorder, or narcissistic personality disorder that predated the diagnosis of schizophrenia or bipolar disorder, or in the opinion of the Investigator, is independent of the signs and symptoms of the schizophrenia or bipolar disorder.
• Female patients who have a positive pregnancy test at screening/baseline or are breastfeeding.
• Currently treated with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin), alpha-2 adrenergic agonists, or other prohibited medications.
• Patients with hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease, or focal neurological findings.
• Patients with ECG abnormalities considered clinically significant by the Investigator or qualified designee with clinical implications for the patient's participation in the study.
• Patients who have received an investigational drug within 30 days prior to Baseline.
• For any reason, patients considered by the Investigator, or designee, to be unsuitable candidates for receiving dexmedetomidine, e.g., patients with a history of allergic reactions to dexmedetomidine.
• Appears to have an impairment (e.g., cognitive, hearing, visual) or insufficient knowledge of the English language that could interfere with their ability to provide written consent, complete written assessments, or an interview (based on screener judgment).
• Unable to accompany the patient and remain present at the clinical site to complete ratings for the full two-hour data collection period while the patient experiences an acute agitation episode that needs to be treated.

Sponsors & Collaborators

• BioXcel Therapeutics Inc: lead
• Premier Research: collaborator

Study Sites (5)

BioXcel Clinical Research Site 103

Chino, California, 91710, United States

Location

BioXcel Clinical Research Site 105

Oceanside, California, 92056, United States

Location

BioXcel Clinical Research Site 102

Orange, California, 92868, United States

Location

BioXcel Clinical Research Site 101

St Louis, Missouri, 63125, United States

Location

BioXcel Clinical Research Site 106

Las Vegas, Nevada, 89119, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia; Psychotic Disorders; Psychomotor Agitation

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Matt Mandel, MD

  BioXcel Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 11, 2025
• Study Start: June 19, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)