CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 438 enrolled
Drug / intervention
Risperidone ISM 75 mg +2 moredrug
Likely dose
Risperidone ISM 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03160521
NCT03160521Phase 3Completed
CompareCT.gov

Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intramuscular Injections of Risperidone ISM® in Patients With Acute Exacerbation of Schizophrenia

Rovi Pharmaceuticals Laboratories·interventional·Posted May 19, 2017·Updated Feb 22, 2022

In Brief

A Phase 3 clinical trial evaluating Risperidone ISM 75 mg, Risperidone ISM 100 mg, and 1 other intervention for Acute Schizophrenia. Completed, enrolled 438 participants across 31 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Schizophrenia
CountriesUkraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 19, 2017
Enrollment StartJun 2, 2017
Primary CompletionDec 17, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.1 years ago

Interventions

Risperidone ISM 75 mgdrug

Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.

Risperidone ISM 100 mgdrug

Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.

Placebo of Risperidone ISMdrug

Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.