# Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia

> **NCT03160521** · PHASE3 · COMPLETED · sponsor: **Rovi Pharmaceuticals Laboratories** · enrollment: 438 (actual)

## Conditions studied

- Acute Schizophrenia

## Interventions

- **DRUG:** Risperidone ISM 75 mg
- **DRUG:** Risperidone ISM 100 mg
- **DRUG:** Placebo of Risperidone ISM

## Key facts

- **NCT ID:** NCT03160521
- **Lead sponsor:** Rovi Pharmaceuticals Laboratories
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-06-02
- **Primary completion:** 2018-12-17
- **Final completion:** 2018-12-17
- **Target enrollment:** 438 (ACTUAL)
- **Last updated:** 2022-02-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03160521

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03160521, "Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT03160521. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
