A Study to Compare the Effectiveness and Safety of Flexibly Varied Doses of Paliperidone Palmitate and Risperidone in Treating Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210717
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 8, 2011
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:
The purpose of this study is to compare the effectiveness and safety over 1 year of treatment of intramuscular injections of paliperidone palmitate and long-acting risperidone in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: paliperidone palmitate Phase 3

Detailed Description:

Paliperidone palmitate is being developed as a long-acting intramuscular injectable formulation for the treatment of schizophrenia. Many patients with schizophrenia achieve symptom stability with the available oral antipsychotic medications; however, it is estimated that up to 75% have difficulty adhering to a daily oral treatment regimen. Long-acting injectable formulations may make compliance with the treatment regimen easier by eliminating the need for daily medication. An injectable formulation of risperidone is widely used in the treatment of schizophrenia and has been well tolerated by patients with chronic schizophrenia at the recommended dosage of 25 to 50 milligrams every 2 weeks. The present study is designed to evaluate the comparability of paliperidone palmitate and long-acting injectable risperidone over 1 year of treatment.

This is a randomized, double-blind, active-controlled, parallel-group, multicenter comparative study in patients with schizophrenia. The study comprises a screening period of up to 1 week (including periods for washout of psychotropic medications and, if necessary, an oral tolerability test) and a 53-week double-blind treatment period. In the double-blind treatment period, patients will be randomly assigned in equal numbers to receive treatment with either (1) flexibly dosed paliperidone palmitate administered every 4 weeks or (2) flexibly dosed long-acting risperidone administered every 2 weeks. Drug effectiveness 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 the double-blind treatment period) or at any subsequent visit for an optional pharmacogenomic (genetic) analysis. The study hypothesis is that paliperidone palmitate will be as effective as long-acting risperidone in the treatment of patients with schizophrenia. Paliperidone palmitate (25, 50, 75, or 100 milligrams (mg) equivalent) every 4 weeks, or long-acting risperidone 25, 37.5, or 50 mg every 2 weeks of double-blind treatment period, injected into the gluteal muscle (buttocks). Oral risperidone (1-6 mg) first 4 weeks of double-blind period

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 748 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel Group, Comparative Study of Flexibly Dosed Paliperidone Palmitate (25, 50, 75, or 100 mg eq.) Administered Every 4 Weeks and Flexibly Dosed RISPERDAL CONSTA (25, 37.5, or 50 mg) Administered Every 2 Weeks in Subjects With Schizophrenia
Study Start Date : February 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated types) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) for at least 1 year before the screening evaluation
  • a total PANSS score of 60 to 120 at screening and baseline (pre-treatment) evaluations
  • a body mass index (BMI [weight (kilograms)]/[height (meters)]²) of at least 15.0 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210717

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00210717     History of Changes
Other Study ID Numbers: CR004195
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: April 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
intramuscular injection
antipsychotic agents
paliperidone palmitate
dementia praecox
mental disorders

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists