Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia
(PRISMA-3 Trial)
Recruiting in Palo Alto (17 mi)
+30 other locations
Overseen byYuriy Filts
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Rovi Pharmaceuticals Laboratories
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of intramuscular (IM) injections of Risperidone ISM® (75 or 100 mg) or placebo, in patients with acute exacerbation of schizophrenia.
Eligibility Criteria
Inclusion Criteria
Capable of providing informed consent
A signed informed consent form must be provided before any study assessments are performed
Patients must be fluent in the language that is spoken by the investigator and the study site staff (including raters) and must be able to read and understand the words in which the informed consent is written
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Treatment Details
Interventions
- Risperidone ISM (Antipsychotic)
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Risperidone ISM 75 mgExperimental Treatment1 Intervention
Patients assigned to this arm will received 75 mg of Risperidone ISM during double-blind treatment period.
Group II: Risperidone ISM 100 mgExperimental Treatment1 Intervention
Patients assigned to this arm will received 100 mg of Risperidone ISM during double-blind treatment period.
Group III: PlaceboPlacebo Group1 Intervention
Patients assigned to this arm will received placebo of Risperidone ISM during double-blind treatment period.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Altea Research InstituteLas Vegas, NV
Pillar Clinical Research LLCRichardson, TX
NRC Research InstituteOrange, CA
Atlanta Center for Medical ResearchAtlanta, GA
More Trial Locations
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Who Is Running the Clinical Trial?
Rovi Pharmaceuticals LaboratoriesLead Sponsor