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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Single dose BXCL501 120 mcg
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
St Louis, Missouri, United States
BioXcel Clinical Research Site 106
Las Vegas, Nevada, United States
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.
Time frame: 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.
Time frame: Within 7 days of the intervention
Patient 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 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.
Time frame: Before and 2 hours after the intervention
Patient training materials assessment
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.
Time frame: Within 7 days of the intervention
Patients completion of the Modified Clinical Global Impression of Severity for Patients (mCGI-S-PAT)
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.
Time frame: Before and 2 hours after the intervention
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