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A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia

NCT01527305 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2024-10-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness and safety of paliperidone palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute schizophrenia (that is within past 4 weeks).

Conditions

Interventions

DRUG

Paliperidone palmitate

Participants will receive 1 intramuscular (into muscle) injection of 150 milligram (mg) on Day 1 and 1 injection of 100 mg on Day 8. Participants will also receive the last 2 paliperidone intramuscular injections between 50 - 150 mg (based on effectiveness and safety profile), on Day 36 and Day 64.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-06-22
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • China
  • Malaysia
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT01527305 on ClinicalTrials.gov