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A Long-term Safety Study for Long-acting Injectable Risperidone in Schizophrenia or Schizoaffective Disorder Patients.

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ClinicalTrials.gov Identifier: NCT00495118
Recruitment Status : Completed
First Posted : July 2, 2007
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Janssen, LP

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: risperidone Phase 3

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 schizophrenia 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : October 2001
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. To document long-term efficacy by measuring mean values and clinical improvement in Positive and Negative Symptoms Scale (Visits 3 & 5 to 10), and Clinical Global Impression scale (Visits 2 to 10), compared with previous and extension baseline.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00495118


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00495118     History of Changes
Other Study ID Numbers: CR002017
First Posted: July 2, 2007    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: May 2010

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

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
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