A Study of Effectiveness and Safety of Paliperidone Extended-release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.

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

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Evaluating Paliperidone Extended Release Tablets in the Prevention of Recurrence in Subjects With Schizophrenia

The purpose of this study is to determine the efficacy (effectiveness) and safety of paliperidone ER compared with placebo in the prevention of recurrence of symptoms of schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Paliperidone ER is currently being investigated as treatment for the acute symptoms of schizophrenia and also as maintenance treatment. This trial is designed to evaluate efficacy and safety of paliperidone ER in prevention of recurrence of psychotic symptoms in patients with schizophrenia. This trial is a randomized (patients will be assigned to different treatment groups based solely on chance), double-blind (neither the patient nor the physician will know if placebo or drug is being given and at what dose), placebo-controlled, parallel-group, multicenter study consisting of 5 phases: a screening phase of up to 5 days; a 8-week open-label run-in phase, during which all patients will be treated with open-label, flexibly dosed paliperidone ER (3 to 15 mg) orally once daily to identify a dose that will achieve control of their acute psychotic symptoms (only patients who maintain a stable dosage regimen and have a total Positive and Negative Syndrome Scale [PANSS] score </=70; Clinical Global Impression Scale - Severity [CGI-S] </=4; and scores of </=4 for PANSS items for delusions, conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, hostility, and uncooperativeness during the last 2 weeks of the run-in phase will be eligible to continue in the stabilization phase); a 6-week open-label stabilization phase, patients who maintain control of their acute psychotic symptoms at the paliperidone ER dosage identified during the run-in phase and meet the total PANSS score, CGI-S, and PANSS items scores throughout the stabilization phase will be randomized to receive either flexibly dosed paliperidone ER, starting at the dose maintained during the stabilization phase of the study, or placebo; a double-blind treatment phase of variable duration, during which patients will be followed until they meet either defined criteria for recurrence or the study ends; a 52-week open-label extension phase for patients who experience a recurrence event during the double-blind phase of the study, or who remain recurrence free for the entire double-blind phase of the study. Efficacy will be assessed using the PANSS and CGI-S scores that will be collected every week, every 2 weeks, or every 4 weeks throughout. Safety assessments include the incidence of adverse events throughout the study; measurement of vital signs (orthostatic pulse rate, orthostatic blood pressure, and temperature); and clinical laboratory tests. In the run-in, double-blind, and open-label extension phases of the study, paliperidone ER or matching placebo will be flexibly dosed in the range 3 to 15 mg orally once a day (3, 6, 9, 12, or 15 mg/day). The dosage in the stabilization phase will be fixed throughout at the dosage that achieved symptom control in the run-in phase.

Study Type

Interventional

Enrollment (Actual)

111

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:

  • DSM-IV diagnosis of schizophrenia at least 1 year before screening
  • experiencing an acute schizophrenic episode with a total PANSS score between 70 and 120
  • agree to be hospitalized for a minimum of 14 days at the start of the study
  • capable of administering study medication themselves or have assistance with study medication administration consistently available throughout the study
  • resided at the same address continuously for at least 30 days prior to screening
  • able and willing to fill out self administered questionnaires
  • washout of antiparkinsonian medications, beta-blockers
  • antiepileptics, lithium 3 days prior to the start of the run-in phase

Exclusion Criteria:

  • DSM-IV Axis I diagnosis other than schizophrenia
  • DSM-IV diagnosis of substance dependence within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
  • preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
  • injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
  • previous history of lack of response to risperidone when acutely psychotic
  • history of neuroleptic malignant syndrome
  • significant risk of suicidal or violent behavior

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
Time to recurrence, defined as the time between randomization to treatment in the double-blind period and the first documentation of a recurrence.

Secondary Outcome Measures

Outcome Measure
Change in PANSS total and subscale scores from randomization to each visit and to the end of the study. Change from baseline in CGI-S at each assessment time point and at endpoint. Incidence of adverse events throughout study.

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

March 1, 2004

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

June 30, 2004

First Submitted That Met QC Criteria

June 30, 2004

First Posted (Estimate)

July 1, 2004

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

  • CR004384

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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