Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Diso… (NCT07116694) | Clinical Trial Compass
CompletedPhase 2
Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
United States33 participantsStarted 2025-06-19
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Has known the patient for at least 12 months cumulatively.
✕
What they're measuring
1
Informant and Clinician ratings comparison
Timeframe: Before and 2 hours after the intervention
. 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.
✕. Psychiatric comorbidities are generally allowed; however, moderate or severe substance use disorders (SUD) (within the past 6 months) are exclusionary if the substance involved is other than nicotine or caffeine.
✕. 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.