Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia

Exclusion Criteria

• •1. Breastfeeding or pregnant
• •2. Symptoms of schizophrenia for more than 20 years at the time of screening.
• •3. Psychotic symptoms that have failed to improve (based on Investigator's opinion or documented medical history) following sufficient treatment with therapeutic doses of two or more anti-psychotics agents over the preceding 2 years
• •4. Prior history of neuroleptic malignant syndrome
• •5. Prior history or current evidence of moderate or severe tardive dyskinesia (mild is acceptable).
• •6. Abnormal ECG evaluation
• •7. History of confirmed epilepsy or prior seizure disorder (history of a single febrile seizure is not exclusionary)
• •8. In the opinion of the investigator, unstable medical disease (e.g., malignancy, poorly controlled diabetes or hypertension, ischemic cardiac disease, dilated cardiomyopathy or valvular heart disease, pulmonary disease, liver disease, kidney disease)
• •9. Acute infectious disease (e.g., malaria, dengue fever, hepatitis A), or chronic infectious disease (e.g., history of AIDS or HIV positivity, tuberculosis)
• •10. Likely allergy, sensitivity or intolerance to BL-1020, perphenazine, risperidone, paliperidone, or any of the drug product excipients
• •11. Any suicide attempt within the preceding 2 years
• •12. Any Substance Dependence disorder
• •13. High likelihood of substance abuse
• •14. Diagnosis with one of the following DSM-IV-TR Axis I diagnoses: schizophreniform disorder, schizoaffective disorder, bipolar disorder, substance dependency, mood disorder with psychotic features; psychotic disorder NOS
• •15. Requiring chronic treatment with benzodiazepines
• •16. Requiring chronic treatment with mood stabilizers
• •17. Previously treated with clozapine within 6 months prior to screening
• •18. Any abnormal clinical laboratory test result that is judged by the Investigator to be clinically significant
• •19. History of, or serologic evidence of, acute or chronic active hepatitis B or C