A Study of the Long-term Safety and Tolerability and the Long-term Effectiveness of Extended-release Oral Paliperidone in Patients Diagnosed With Schizophrenia

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

Open-label Extension of A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 2 Fixed Dosages of Extended Release OROS� Paliperidone (6 and 12 mg/Day) and Olanzapine (10 mg/Day), in Patients With Schizophrenia

The purpose of this study is to evaluate the long-term safety and tolerability and the maintenance of effectiveness of a slow, extended-release oral formulation of paliperidone administered once daily to patients diagnosed with schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The controlled rate of drug delivery provided by the extended-release oral formulation of paliperidone may provide improved effectiveness and a reduced risk of certain adverse effects in patients with schizophrenia, by avoiding peaks and troughs of drug levels in the blood. This could in turn provide an improved quality of life and overall functioning for patients.

This open-label study is an extension of a 6-week randomized, double-blind, parallel-group study in which the effectiveness and safety of 4 different oral treatments administered once daily are compared in patients with schizophrenia: paliperidone 6 or 12 milligrams (mg), olanzapine 10 mg (an approved treatment for schizophrenia), or placebo. Following the double-blind treatment phase, eligible patients may enter this 52-week open-label extension with slow, extended-release paliperidone (with no comparison treatments). In the open-label extension, all patients, regardless of their randomized treatment in the double-blind phase, will begin on extended-release paliperidone 9 mg once daily. Thereafter, patients will be maintained on a flexible dosage of extended-release paliperidone throughout the 52-week study. The dosage may be increased or decreased within this range in accordance with the clinical judgment of the investigator, based on observations of patient response and tolerability. Because flexible dosing more closely mimics clinical practice, this design may provide more clinically relevant findings in the open-label setting.The final visit in the double-blind phase may serve as the initial visit for the open-label extension. Study visits will occur at Day 4 and then weekly for the first 4 weeks (Weeks 1, 2, 3, and 4) and then every 4 weeks through Week 52 or until early termination. Evaluations of the safety and effectiveness of extended-release paliperidone treatment will be performed at scheduled times throughout the open-label extension. Flexible dosage (3, 6, 9, or 12 milligrams (mg)) extended-release paliperidone tablets administered orally once daily for 52 weeks, following a 6-week double-blind study in which patients receive fixed oral doses of 6 mg or 12 mg extended-release paliperidone or olanzapine 10 mg.

Study Type

Interventional

Enrollment (Actual)

203

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:

  • As for the double-blind study, a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
  • experiencing an acute episode of schizophrenia at time of screening for the double-blind study, with a total PANSS score of 70 to 120
  • completed the double-blind study or discontinued after at least 21 days of double-blind treatment because of lack of efficacy
  • for female patients of childbearing potential, agreement to continue to use an acceptable form of contraception throughout the open-label extension, with a negative urine pregnancy test at open-label baseline.

Exclusion Criteria:

  • As for the double-blind study, a DSM-IV axis I diagnosis other than schizophrenia
  • a DSM-IV diagnosis of substance dependence within 6 months prior to screening for the double-blind study
  • considered by the investigator to be at significant risk for suicidal or violent behavior during the open-label study
  • received an injection of a depot antipsychotic since entry into the double-blind study
  • a woman who has become pregnant.

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Standard safety evaluations, and monitoring of extrapyramidal symptoms (tardive dyskinesia, akathisia) by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS), throughout the long-term study.

Secondary Outcome Measures

Outcome Measure
Assessment of long-term effectiveness by the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale - Severity (CGI-S), Personal and Social Performance Scale (PSP), and Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4).

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

January 1, 2004

Study Completion (ACTUAL)

December 1, 2005

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)

May 18, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004426

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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