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A Long-Term Safety Study for Long-Acting Injectable Risperidone in Schizophrenia or Schizoaffective Disorder Patients
This study has been completed.
Sponsored by: Janssen, LP
Information provided by: Janssen, LP
ClinicalTrials.gov Identifier: NCT00495118
  Purpose

The purpose of this study is to document the long-term safety of 25, 37.5, or 50 mg long-acting injectable risperidone given via injection to the gluteal muscle every 2 weeks to subjects with schizophrenia or schizoaffective disorder.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: risperidone
Phase III

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Risperidone Depot (Microspheres) in the Treatment of Subjects With Schizophrenia or Schizoaffective Disorder - an Open-Label Follow-up Trial of RIS-INT-62 and RIS-INT-85.

Further study details as provided by Janssen, LP:

Primary Outcome Measures:
  • To document the long-term safety of 25, 37.5 and 50 mg long-acting injectable risperidone from baseline until study end point.

Secondary Outcome Measures:
  • To document long-term efficacy by measuring mean values and clinical improvement in Positive and Negative Symptoms Scale (Visits 3 and 5 to 10), and Clinical Global Impression scale (Visits 2 to 10), compared with previous baseline and extension baseline

Estimated Enrollment: 440
Study Start Date: October 2001
Study Completion Date: March 2005
Detailed Description:

Noncompliance in taking medication is very common among people with schizophrenia, and is a frequent cause of relapse of symptoms. A long-acting injectable formulation that ensures slow but steady release of risperidone over a period of several weeks would eliminate the need to take medication on a daily basis, and improve compliance. This is an open-label, international, multicenter study in subjects with scizophrenia or schizoaffective disorder who completed the risperidone microspheres arm of study RIS-INT-62, or who completed study RIS-INT-85, or who dropped out of the risperidone microspheres arm of study RIS-INT-62 due to treatment with 75 mg long-acting injectable risperidone. Patients have to begin this study within 7 days of the final visit in the RIS-INT-62 or RIS-INT-85 studies. The end point visit of the RIS-INT-62 or RIS-INT-85 study serves as the first visit of this open-label study. Patients can start this study on the same dose as the last risperidone microsphere injection that they received in the previous study, or at a dose that was 12.5 mg lower or higher than the previously received dose. Patients who received 75 mg risperidone microsphere injection during study RIS-INT-62 can continue on this dose but an attempt will be made to decrease the dose to 50 mg within 3 months. The total study duration is planned to be at least 1 year or until approval of long-acting injectable risperidone in the respective country. The study hypothesis is that treatment with the long-acting injectable formulation of risperidone every 2 weeks for at least 1 year will be safe and well tolerated, as assessed by adverse event reporting, the extrapyramidal symptom rating scale, laboratory tests, vital signs measurements, physical examinations, body weight measurements, electrocardiograms, and injection site evaluations.

Patients will receive injections of risperidone depot microspheres (25, 37.5, 50, or 75 mg) in their gluteal muscle at 2-weekly intervals for at least 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia (patients from RIS-INT-62 or RIS-INT-85) or schizoaffective disorder (patients from RIS-INT-62 only) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
  • Patient completed the risperidone microspheres arm of RIS-INT-62, or completed RIS-INT-85, or dropped out of the risperidone microspheres arm of RIS-INT-62 due to treatment with 75 mg long-acting injectable risperidone
  • Informed consent signed by the patient
  • Patient is otherwise healthy on the basis of a prestudy physical examination and medical history

Exclusion Criteria:

  • A DSM-IV Axis I diagnosis other than schizophrenia or schizoaffective disorder
  • No pregnant or breast-feeding women
  • No female patient of childbearing potential without adequate contraception
  • No history of severe drug allergy or hypersensitivity
  • No subjects known to be unresponsive to risperidone
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495118

Sponsors and Collaborators
Janssen, LP
Investigators
Study Director: Janssen, LP Clinical Trial Janssen, LP
  More Information

A long-term safety study for long-acting injectable risperidone in schizophrenia or schizoaffective disorder patients.  This link exits the ClinicalTrials.gov site

Study ID Numbers: CR002017
Study First Received: June 29, 2007
Last Updated: September 26, 2008
ClinicalTrials.gov Identifier: NCT00495118  
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen, LP:
schizophrenia
intramuscular injection
schizoaffective disorder
long-acting injectable
risperidone

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009