Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210691
Status:
COMPLETED
Last Update Posted:
2010-11-19
First Post:
2005-09-13
Brief Title:
A Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Risperidone Depot Microspheres in the Treatment of Subjects With Schizophrenia or Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2010-11
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 and tolerability of risperidone formulated as a long-acting injectable in the treatment of patients with schizophrenia or schizoaffective disorder in addition to evaluate the long-term effectiveness of long-acting risperidone and its effect on quality of life
Detailed Description:
Although many schizophrenia patients currently take oral antipsychotic medications it is estimated that up to 75 of them have difficulty adhering to the daily oral regimen Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen This safety study is an extension of a randomized double-blind multicenter parallel group study that investigates effectiveness and safety of risperidone injected intramuscularly in patients with schizophrenia or schizoaffective disorder The present open-label study evaluates 3 different doses of a formulation of risperidone injected into the muscle at 2 week intervals for at least 1 year in patients with these conditions Assessments of effectiveness include the Clinical Global Impression CGI overall severity of illness scale Quality of life will be assessed by the SF-36 Health Survey Safety evaluations include incidence of adverse events physical examinations and evaluations of the injection site clinical laboratory tests electrocardiograms ECGs and Extrapyramidal Symptom Rating Scale ESRS a scale assessing muscle tone gain and abnormal movements Injections every 2 weeks for at least 1 year beginning at 25milligramsmg and increasing to 50mg or 75mg maximum dose Dosages may be increased or decreased at investigators discretion During the first 3 weeks risperidone tablets 2mg once daily to supplement injectable risperidone
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