A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia

June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (50 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia

The purpose of this study is to evaluate the effectiveness and safety of 3 doses of paliperidone palmitate in treating subjects with schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose-response study of patients who have a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) diagnosis of schizophrenia. The duration of the study is approximately 14 weeks, including a screening period of 1 week and a 13-week double-blind treatment period. Efficacy and safety will be evaluated periodically throughout the study. Samples for pharmacokinetic evaluation will be collected at designated time points, and a blood sample will be collected at baseline (before the start of double-blind treatment) for an optional pharmacogenomics (genetics) analysis. The hypothesis is that the 3 fixed doses of paliperidone are each more efficacious than placebo in treating subjects with schizophrenia. The effectiveness is measured primarily by the change in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), and secondarily, by the investigator's Clinical Global Impression of Severity (CGI-S) and by the investigator's evaluation of the patient on a Personal and Social Performance (PSP) Scale. Four injections of paliperidone palmitate 50, 100, or 150 milligrams equivalent administered in the gluteal muscle (buttocks). Injections will be given on Days 1, 8, 36, and 64 of the double-blind treatment period of the study.

Study Type

Interventional

Enrollment (Actual)

366

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A DSM-IV diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated type) for at least 1 year before the screening evaluation
  • a total PANSS score of 70 to 120 at screening and baseline (pre-treatment) evaluations
  • a body mass index (BMI [weight (kilograms)]/[height (meters)]²) of more than 17.0 kg/m²

Exclusion Criteria:

  • A primary active DSM-IV Axis I diagnosis other than schizophrenia
  • a decrease of 25% or more in the total PANSS score between screening and baseline evaluations
  • a DSM-IV diagnosis of active substance dependence within 3 months of screening evaluation
  • a history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
  • a woman who is pregnant, breast-feeding, or planning to become pregnant during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The change in the total score of the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.

Secondary Outcome Measures

Outcome Measure
The investigator's Clinical Global Impression of the Severity (CGI-S) of schizophrenia and rating of mental function on a Personal and Social Performance Scale (PSP). Evaluations of adverse events, laboratory tests, and other measures of drug safety.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion (ACTUAL)

June 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 21, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002353

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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