Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension

An individual who meets any of the following criteria at the extension baseline time point (immediately upon completion of the end-of-treatment visit assessments and procedures for the double blind segment PRISMA-3) will not be permitted to enter into this extension segment of the study PRISMA-3:

1. Missed more than 1 scheduled study visit during participation in the double blind segment of study PRISMA-3

2. Had an abnormal clinical laboratory value, vital sign, or ECG finding during participation in the main part of the study that, in the opinion of the investigator, was clinically relevant, related to study drug, and would compromise the well-being of the patient in the extension segment

3. Had a clinically significant or unstable medical illness/condition/disorder during the main part of the study that would be anticipated, in the investigator's opinion, to potentially compromise patient safety in the extension segment

4. Is taking or is anticipated to require any prohibited concomitant medication

5. Pregnant, lactating, or breastfeeding

6. Any contraindication for continued IM injections (e.g., treatment with anticoagulant)

7. Inadequate gluteal or deltoid musculature or excessive fat, as determined by the investigator, that would interfere with IM study drug injections

8. Study site personnel and/or persons employed by the investigator or study site or is an immediate family member of such persons

1. History of proven inadequate clinical response to treatment with therapeutic doses (with good compliance) of risperidone or paliperidone

2. History of treatment resistance, defined as failure to respond to 2 discrete adequate trials (≥ 4 weeks with an adequate dose) of 2 different antipsychotic medications; history of clozapine use (exception: use was not because of treatment resistance or refractory psychotic symptoms)

3. Known or suspected intolerance of or allergy or hypersensitivity to risperidone, paliperidone, or any of the excipients in the IM formulations of these

4. History of neuroleptic malignant syndrome, clinically significant tardive dyskinesia or tardive dystonia

5. History of any other medical condition that is considered to pose any unjustifiable risk or interfere with study assessments

6. Clinically significant extrapyramidal symptoms at screening or baseline

7. At significant risk of suicidal, homicidal or violent ideation or behavior, by history or as clinically assessed by the investigator at screening visit

8. Answer of "yes" on item 4 or on item 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) (ideation) with the most recent episode occurring within the past 2 months, or answer "yes" to any of the 5 items (behavior) with an episode occurring within the last year

9. Current diagnosis or a history of substance use disorder according to DSM-5 criteria within 6 months prior to the screening visit (with the exception of tobacco, mild cannabis, or mild alcohol use disorder) or a positive drug screen test (with the exception of cannabis) verified by repeat testing

10. Lifetime history of diagnosis of schizoaffective disorder or bipolar disorder

11. Clinically significant comorbid neuropsychiatric disorders

12. Clinically significant or unstable medical illness/condition/disorder that would be anticipated, in the investigator's opinion, to potentially compromise patient safety or adversely affect the evaluation of efficacy

13. Laboratory abnormality that, in the opinion of the investigator, would compromise the well-being of the patient, or any of the following laboratory abnormalities at screening or baseline

14. Pregnant, lactating, or breastfeeding

15. Inadequate gluteal or deltoid musculature or excessive fat, as determined by the investigator, that would interfere with IM study drug injections

16. Any contraindication for IM injections

17. Receipt of any long-acting antipsychotic medication by IM injection within 60 days before screening

18. Current involuntary hospitalization or incarceration

19. Hospitalized for more than 30 days during the 90 days before screening

20. Participation in another clinical study in which the patient received an experimental or investigational drug or agent within 6 months before screening

21. Participation in a clinical study with Risperidone ISM within 12 months before screening

22. Study site personnel and/or persons employed by the investigator or study site or is an immediate family member of such persons

23. Patients taking or anticipated to require any prohibited concomitant medication

What this study is about