Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236587
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-10-07
Brief Title:
A Long Term Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Open Label Long Term Trial of Risperidone Long Acting Microspheres in the Treatment of Patients Diagnosed With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to document the long term safety of a long-acting injectable formulation of risperidone in the treatment of patients with schizophrenia who have previously been treated with long-acting risperidone Efficacy will also be evaluated
Detailed Description:
This is an open-label long-term study of a flexible dose of a long-acting injectable formulation of risperidone risperidone LAI injected into the muscle at 2 week intervals for at least 12 months in patients diagnosed with schizophrenia It is an extension of an open label study of patients with schizophrenia RIS-USA-259 switching from treatment with an oral antipsychotic medication to long-acting injectable risperidone Safety evaluations include incidence of adverse events physical examinations clinical laboratory tests biochemistry hematology and urinalysis electrocardiograms ECGs and Extrapyramidal Symptom Rating Scale ESRS a scale for assessing muscle tone gait and abnormal movements Efficacy assessments include measurements using the Positive and Negative Syndrome Scale for Schizophrenia PANSS and the Clinical Global Impression-Severity of Illness scale CGI-S Risperidone 25-50milligrams mg injections long-acting formulation every 2 weeks for at least 1 year Dosages may be increased 50 mgs maximum or decreased at discretion of the investigator Supplementary risperidone tablets 1mg may be administered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None