A Study of How Long it Takes a Patient to Relapse After Switching From an Oral Antipsychotic to One of Two Doses of Long-acting Risperidone Injections in Patients With Schizophrenia or Schizoaffective Disorder

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

A 52-wk Prospective, Randomized, Double-blind, Multicenter Study of Relapse Following Transition From Oral Antipsychotic Medication to 2 Different Doses (25 or 50 mg Every 2 Wks) of Risperidone Long-acting Microspheres (Risperdal� CONSTA�) in Adults With Schizophrenia or Schizoaffective Disorder

The purpose of this study is to assess the time for patients to relapse when switched from an oral antipsychotic to one of two doses of long-acting risperidone injection (shots). Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Results from studies of older long-acting injectable antipsychotics (not risperidone) show that patients tend to relapse (which means start having symptoms again) when they are given low doses. However, increasing the dose may cause more side effects. This study will measure the time to relapse during a 52-week period in patients with schizophrenia or schizoaffective disorder who are switched from an oral antipsychotic (one taken by mouth) to one of two doses of long-acting risperidone injections (shots). The patients will be assigned to a dose of either 25 or 50 milligrams per injection every 2 weeks. Patients continue to take their usual oral antipsychotic medications up to 3 weeks following the first injection. After this 3-week period, they will receive the injectable risperidone only. Patients will be asked questions at each visit to help determine the effectiveness of the drug as assessed by the Clinical Global Impression Scale and the Positive and Negative Syndrome Scale. The safety of the drug will be based on patient signs and symptoms assessed according to the Extrapyramidal Symptom Rating Scale and self-reported treatment-emergent adverse events. Long-acting risperidone injection, 25 or 50 milligrams per injection, every 2 weeks for 52 weeks. Patients will continue to take their current oral antipsychotics for up to 3 weeks following the first injection of risperidone.

Study Type

Interventional

Enrollment (Actual)

40

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with schizophrenia or schizoaffective disorder
  • stable with respect to disease symptoms and other medical conditions
  • stable on any oral antipsychotic drug (except clozapine) for 4 weeks before the study
  • patients identify a relative or acquaintance who can complete a questionnaire with additional information about the patient
  • if female, using birth control.

Exclusion Criteria:

  • Patient is not eligible if currently hospitalized, or was treated for an acute disease-related crisis within the past 4 weeks
  • at risk to self or others
  • use of injectable antipsychotic drugs or electroconvulsive therapy within past 6 months, or currently using carbamazepineor an oral antipsychotic drug in a dose that is higher than 8 milligrams per day in risperidone equivalents, of long-acting risperidone in an earlier study, of clozapine, or use of investigational drugs within 30 days, or of electroconvulsive therapy within past 6 months
  • presence of liver or kidney damage
  • history of neuroleptic malignant syndrome
  • if pregnant or breast-feeding
  • not using birth control
  • abusing drugs or alcohol.

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
Risperidone effectiveness is measured by time to relapse within the 52 week period.

Secondary Outcome Measures

Outcome Measure
Effectiveness of the drug is assessed by the Clinical Global Impression Scale and Positive and Negative Syndrome Scale; safety as assessed by the Extrapyramidal Symptom Rating Scale and treatment-emergent adverse events during the 52 week period.

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 Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

February 24, 2006

First Submitted That Met QC Criteria

February 24, 2006

First Posted (Estimate)

February 28, 2006

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

  • CR002899

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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