Evaluation of Effectiveness and Safety of Paliperidone ER (Extended-release) Compared With Quetiapine in Patients With Schizophrenia

May 17, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Paliperidone ER Compared to Quetiapine in Subjects With an Acute Exacerbation of Schizophrenia

The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to placebo in patients who are acutely ill with symptoms of schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized (patients are assigned different treatments based on chance), double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo controlled, parallel group study to compare the efficacy and safety of paliperidone ER with quetiapine in the treatment of patients who have schizophrenia and are acutely ill. The duration of the study is 42 days. During the first phase (Day 0 - Day 14) patients receive increasing doses of the treatment to which they are assigned (starting with 3mg and increasing to 9 mg or 12 mg of paliperidone ER; starting with 50 mg and increasing to 600 mg or 800 mg of quetiapine; or the same number of capsules of placebo). During the second phase (Day 15 - Day 42), patients continue to take the dose of medication they received on day 14, but may also receive other medications if the investigator determines they are needed to treat ongoing symptoms. The hypothesis of the study is that paliperidone ER is better than quetiapine in the short term for treating acutely ill patients with schizophrenia. Primary outcome is change on the total score of the PANSS (Positive and Negative Syndrome scale for Schizophrenia) in the first phase of the study (Day 0 - Day 14). Secondary outcomes include time to response, time to readiness for discharge, and additional medication use in the second phase of the study (Day 15- Day 42) for patients receiving paliperidone ER compared to quetiapine. Safety of paliperidone ER compared with quetiapine throughout the study (Day 0 - Day 42) will be based on reported adverse events, results of laboratory tests (hematology, biochemistry, and urinalysis), vital signs (blood pressure, pulse, and weight), electrocardiogram, and movement disorder scales (Abnormal Involuntary Movement Scale, Barnes Akathisia Scale, and Simpson-Angus Rating Scale). Patients may participate in a pharmacogenomic (DNA) analysis, if they choose to do so. Patients receive study drug by mouth for a total of 42 days. Study medications will be increased to maximum tolerated doses of Paliperidone ER 9mg or 12mg/day and Quetiapine 600mg or 800mg at day 8. From day 15 through day 42 (end of study) all patients will be eligible for additional psychotropic medications at investigators' discretion.

Study Type

Interventional

Enrollment (Actual)

399

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizophrenia (paranoid, disorganized or undifferentiated type)
  • score of >=4 on at least two of a subset of selected PANSS items and a total score on these five items of >=17
  • score of >=5 on the CGI-S (clinical global impression - severity)
  • body weight of at least 60kg and willing to be hospitalized for 9 days initially

Exclusion Criteria:

  • A primary active mental illness diagnosis other than schizophrenia
  • subjects whose psychotic symptoms can be explained by substance intake or medical illness
  • pregnancy, breast-feeding, or planning to become pregnant
  • a history of treatment resistance (defined by failure to respond to 2 adequate trials of different antipsychotic medications or clozapine given at adequate dose for sufficient time)
  • unstable or significant medical illness that would increase risk of taking study medication or would confuse the interpretation of the study

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 Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction in total PANSS ( Positive and Negative Syndrome Scale) from baseline to endpoint at Day 14

Secondary Outcome Measures

Outcome Measure
Time to response (based on reduction in PANSS plus Clinical Global Impression - Change) and readiness for discharge, utilization of health care resources and polypharmacy use in patients receiving paliperidone ER or quetiapine

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.

Collaborators

Janssen, LP

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, 2006

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

June 2, 2006

First Submitted That Met QC Criteria

June 2, 2006

First Posted (Estimate)

June 6, 2006

Study Record Updates

Last Update Posted (Estimate)

May 18, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR010501

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.

Subscribe