Saturday, July 27, 2019 7:59:22 AM
The consortium trial is for the purpose of establishing biomarkers for schizophrenia, so a "normal" and a diagnosed population will have data collected, it will be analyzed with AI and ERP patterns will be identified that can be used to objectively evaluate disease severity and drug response. After these biomarkers are determined a single arm trial could be short and sweet.
Schizophrenia is also episodic, so even without drug intervention biomarkers could create an early warning system that would help patients manage their disease.
Schizophrenia
Definition
Schizophrenia is a mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. Although the course of schizophrenia varies among individuals, schizophrenia is typically persistent and can be both severe and disabling.
Symptoms of schizophrenia include psychotic symptoms such as hallucinations, delusions, and thought disorder (unusual ways of thinking), as well as reduced expression of emotions, reduced motivation to accomplish goals, difficulty in social relationships, motor impairment, and cognitive impairment. Although symptoms typically start in late adolescence or early adulthood, schizophrenia is often viewed from a developmental perspective. Cognitive impairment and unusual behaviors sometimes appear in childhood, and persistent presence of multiple symptoms represent a later stage of the disorder. This pattern may reflect disruptions in brain development as well as environmental factors such as prenatal or early life stress. This perspective fuels the hope that early interventions will improve the course of schizophrenia which is often severely disabling when left untreated.
https://www.nimh.nih.gov/health/statistics/schizophrenia.shtml
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