Bipolar I Disorder, Bipolar II Disorder, Psychomotor Agitation, Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorders
Conditions
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.
Interventions
DRUGBXCL501 Sublingual Film
Single dose BXCL501 120 mcg
Sponsors
BioXcel Therapeutics Inc
Premier Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
for Participant: 1. Male and female patients 18 to 75 years old, inclusive. 2. Patients who can read, understand, and provide written informed consent. 3. 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. 4. 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). 5. 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. 6. Based on history, in the past 30 days prior to Screening, patients must have had at least one clinical presentation of agitation requiring intervention. 7. 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. Inclusion Criteria for Informant: 1. At least 18 years of age at the time of screening. 2. Is a spouse, significant other, family member, friend, home health aide, or residence manager of an adult patient who: 1. Has a clinical diagnosis of bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder. 2. Is determined to be eligible for the study per the patient inclusion/
Exclusion criteria
. 3. Has known the patient for at least 12 months cumulatively. 4. Currently living with or routinely contacting the patient at least five days a week. 5. Does not plan to discontinue contact with the patient during the study period. 6. Willing and able to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
STUDY_CHAIRBioXcel MM
BioXcel Therapeutics
Outcome results
None listed