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

Sponsored by:	Janssen, LP
Information provided by:	Janssen, LP
ClinicalTrials.gov Identifier:	NCT00558298

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
Schizoaffective Disorder Schizophrenia	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, 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-57 and RIS-INT-61.

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.

Estimated Enrollment:

810

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

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

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

This link exits the ClinicalTrials.gov site

Study ID Numbers:

CR002023

First Received:

November 12, 2007

Last Updated:

March 17, 2008

ClinicalTrials.gov Identifier:

NCT00558298

Health Authority:

United States: Institutional Review Board

Keywords provided by Janssen, LP:

schizoaffective disorder
risperidone
long-acting injectable
intramuscular injection
schizophrenia

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 07, 2009