Intervention: Risperidone
Trial phase: Phase 2 | Phase 3
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 136
Group description: 2-6 mg, 6 months

Risperidone
Eligibility criteria:
Inclusion Criteria:

Male or non-pregnant or lactating female, 18-50 years of age inclusive
Patients must have exhibited symptoms meeting the criteria of schizophrenia for at least one year, but not more than 20 years, prior to Screening
Recent onset (not more than 30 days) of worsening of psychiatric symptoms at Screening.

Currently experiencing an acute exacerbation of schizophrenia, as defined by the following results at Screening and Baseline:

≥70 total score on the PANSS
≥4 (moderate) on two of the following four PANSS items: (1) delusions, (2) hallucinatory behaviors, (3) conceptual disorganization or (4) suspiciousness/persecution, where at least one of the two items must be either delusions or hallucinatory behaviors
CGI-S score between 4 and 6 (moderately ill to severely ill) at the Screening and Baseline visits.
Has exhibited a sufficient clinical response to at least one previous course of an anti-psychotic agent prescribed at a generally recognized therapeutic dose.
Must have completed at least 5 years of formal education or its equivalent

Exclusion Criteria:

Breastfeeding or pregnant
Symptoms of schizophrenia for more than 20 years at the time of screening.
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
Prior history of neuroleptic malignant syndrome
Prior history or current evidence of moderate or severe tardive dyskinesia (mild is acceptable).
Abnormal ECG evaluation
History of confirmed epilepsy or prior seizure disorder (history of a single febrile seizure is not exclusionary)
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)
Acute infectious disease (e.g., malaria, dengue fever, hepatitis A), or chronic infectious disease (e.g., history of AIDS or HIV positivity, tuberculosis)
Likely allergy, sensitivity or intolerance to BL-1020, perphenazine, risperidone, paliperidone, or any of the drug product excipients
Any suicide attempt within the preceding 2 years
Any Substance Dependence disorder
High likelihood of substance abuse
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
Requiring chronic treatment with benzodiazepines
Requiring chronic treatment with mood stabilizers
Previously treated with clozapine within 6 months prior to screening
Any abnormal clinical laboratory test result that is judged by the Investigator to be clinically significant
History of, or serologic evidence of, acute or chronic active hepatitis B or C