This is a Phase 1B clinical study evaluating the safety and exploring the effectiveness of SP-624 as compared to placebo in the treatment of adults with schizophrenia experiencing acute psychosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
Collaborative Neuroscience Research
Garden Grove, California, United States
Hassman Research Institute
Marlton, New Jersey, United States
Incidence of Adverse Events (AEs)
Time frame: Up to 8 weeks
Number of Participants with Abnormal Clinical Laboratory Values
chemistry, hematology, and urinalysis tests will be performed
Time frame: Up to 4 weeks
Change from Baseline in Blood Pressure (mmHg)
Blood pressure is measured by sphygmomanometer. Change from baseline measurement will be calculated
Time frame: Up to 4 weeks
Change from Baseline in Pulse Rate (beats per minute)
Pulse rate is measured by sphygmomanometer. Change from baseline measurement will be calculated
Time frame: Up to 4 weeks
Change from Baseline in Body Temperature (degrees celsius)
Body temperature is measured by oral thermometer. Change from baseline measurement will be calculated
Time frame: Up to 4 weeks
Change from Baseline in Body Weight (kilograms)
Body weight is measured by weight scale. Measurement is reported in kilograms. Change from Baseline measurement will be calculated.
Time frame: Up to 4 weeks
Change from Baseline in ECG Heart Rate (beats per minute)
Heart rate is measured by 12-lead electrocardiogram (ECG). Change from Baseline measure will be calculated.
Time frame: Up to 4 weeks
Change from Baseline in ECG RR Interval (seconds)
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RR interval is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Time frame: Up to 4 weeks
Change from Baseline in ECG PR Interval (milliseconds)
PR interval is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Time frame: Up to 4 weeks
Change from Baseline in ECG QTcF Interval (milliseconds)
QTcF is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Time frame: Up to 4 weeks
Number of Participants with Abnormal Physical Examination Findings
Time frame: Up to 4 weeks
Number of Participants with treatment-emergent suicidal ideation or behavior
Treatment-emergent suicidal ideation and/or behavior will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) assessments
Time frame: Up to 5 weeks
Number of Participants with treatment-emergent abnormal movements
Treatment-emergent abnormal movements will be assessed using a battery of movement assessments
Time frame: Up to 4 weeks