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

NCT03160521 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2022-02-22

Study results available
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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.

Conditions

  • Acute Schizophrenia

Interventions

DRUG

Risperidone ISM 75 mg

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

DRUG

Risperidone ISM 100 mg

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

DRUG

Placebo of Risperidone ISM

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

Sponsors & Collaborators

  • Rovi Pharmaceuticals Laboratories

    lead INDUSTRY

Principal Investigators

  • Robert Litman · CBH Health LLC

  • Yuriy Filts · CI Lviv Regional Clinical Psychiatric Hospital. Department 25

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-02
Primary Completion
2018-12-17
Completion
2018-12-17
FDA Drug
Yes

Countries

  • United States
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03160521 on ClinicalTrials.gov