This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Age 18-65
* Primary diagnosis of schizophrenia
* Clinical laboratory values within normal range or \< 1.5 times ULN
* Currently prescribed only one antipsychotic medication, with stable dose for at least 4 weeks
* Able and willing to provide written informed consent
Exclusion Criteria:
* Any physical or psychological condition that prohibits study completion
* Known cardiac disease
* Active or history of malignancy in the past 5 years
* History of clinically significant CNS event or diagnosis in the past 5 years.
* Receipt of investigational products within 30 days
* Blood donation within 30 days
Primary outcome measure(s)
Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician — 6 weeks The PANSS is a scale to measure symptom severity of schizophrenia. Thirty symptoms of schizophrenia are evaluated by a clinician on a seven point sale, with 1 = absence of symptoms and 7 = extremely severe symptoms. This study will rate each score change by calculating the difference between baseline scale and completion of study intervention.
Electroencephalogram analysis to assess brain electrical activity — 6 weeks Electroencephalograms (EEG) will provide a non-invasive measurement of brain activity. This test will be used to measure specific brain responses to stimuli, including attention and decision making electrical activity and detection of unexpected changes in the auditory environment.
Change in smooth pursuit eye tracking from baseline — 6 weeks Participants will follow visual targets on a computer screen to assess for accuracy of following the item, and smoothness of eye movements. The visual target on the computer screen will follow several different tracking patterns and at various speeds.
Trial sites (3)
Facility
City
Region
Status
CenExel CNS
Garden Grove
California
Box Hill Hospital - Eastern Health
Box Hill
Victoria
Multidisciplinary Alfred Psychiatry Research Centre (MAPrc)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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