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A Long Term Study of Safety for Long Acting Injectable Risperidone in Patients With Schizophrenia or Schizoaffective Disorder.

This study has been completed.
Sponsor:
Information provided by:
Janssen, LP
ClinicalTrials.gov Identifier:
NCT00558298
First received: November 12, 2007
Last updated: May 16, 2011
Last verified: April 2010
  Purpose

The purpose of this study is to document the long-term safety of 25, 50 or 75 mg long-acting injectable risperidone given via injection to the gluteal muscle every 2 weeks to patients with schizophrenia or schizoaffective disorder.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: 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-57 and RIS-INT-61.

Resource links provided by NLM:


Further study details as provided by Janssen, LP:

Primary Outcome Measures:
  • To document the long-term safety of 25, 50 and 75 mg long-acting injectable risperidone from baseline until study endpoint.

Secondary Outcome Measures:
  • The mean values and change from baseline in Clinical Global Impression scale (CGI) at each time point until study endpoint.

Enrollment: 811
Study Start Date: February 2000
Study Completion Date: February 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 the 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 patients with schizophrenia or schizoaffective disorder who either completed study RIS-INT-57 or RIS-INT-61 or who dropped out of RIS-INT-61 after the completion of 3 injection cycles. Patients have to begin this study within 7 days of the final endpoint visit in the RIS-INT-57 or RIS-INT-61 studies. The endpoint visit of RIS-INT-57 and RIS-INT-61 serves as the first visit (Visit 1) of RIS-INT-63, and is considered the baseline of this extension study. Patients who have completed RIS-INT-57 will continue to receive the same dose of long-acting injectable risperidone (25, 50 or 75 mg) as they received during the last 3 months of that study. Patients who have completed or dropped out of RIS-INT-61 will continue to receive the same or equivalent dose of long-acting injectable risperidone as they had received during that study. The blind will not be broken for patients from the RIS-INT-61 study, therefore they will continue to receive double-blind oral medication for the first 3 weeks of this extension study. The total study duration is planned to be at least 1 year. 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 in microspheres (25, 50 or 75 mg) in their 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-57 or RIS-INT-61) or schizoaffective disorder (patients from RIS-INT-57 only) according to the DSM-IV criteria
  • patient completed RIS-INT-57 or RIS-INT-61 or dropped out after completion of 3 injection cycles in RIS-INT-61 (i.e., at or after Visit 4)
  • Patient was otherwise healthy on the basis of a prestudy physical examination and medical history.

Exclusion Criteria:

  • No DSM-IV diagnosis of substance abuse or dependence within 3 months prior to entry in RIS-INT-57 or RIS-INT-61 (excluding nicotine and caffeine dependence)
  • No pregnant or breast-feeding women
  • No female patient of childbearing potential without adequate contraception
  • No history of severe drug allergy or hypersensitivity
  • No patients known to be unresponsive to risperidone.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558298

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00558298     History of Changes
Other Study ID Numbers: CR002023
Study First Received: November 12, 2007
Last Updated: May 16, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014