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

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.

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: risperidone

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.

• Study Type: Interventional
• Enrollment (Actual): 811
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Janssen, LP

Publications and helpful links

Helpful Links

• A long term safety study for long acting injectable risperidone in schizophrenia or schizoaffective disorder patients.

Study record dates

Study Major Dates

• Study Start: February 1, 2000
• Study Completion (ACTUAL): February 1, 2005

Study Registration Dates

• First Submitted: November 12, 2007
• First Submitted That Met QC Criteria: November 12, 2007
• First Posted (ESTIMATE): November 14, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): May 17, 2011
• Last Update Submitted That Met QC Criteria: May 16, 2011
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: schizophrenia; risperidone; schizoaffective disorder; intramuscular injection; long-acting injectable
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: CR002023