Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216632
Status:
COMPLETED
Last Update Posted:
2012-12-07
First Post:
2005-09-13
Brief Title:
A Study of Treatment Success in Changing From Olanzapine to Long-acting Injectable Risperidone RISPERDAL CONSTA
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
Treatment Success in Patients Requiring Treatment Change From Olanzapine to Risperidone Long Acting Injectable TRESOR
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the maintained effectiveness of long-acting injectable risperidone RISPERDAL CONSTA compared with the previous treatment with oral olanzapine in non-acute subjects with schizophrenia or schizoaffective disorder considered in need of a therapy change
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 In addition transitioning to a different antipsychotic drug is at times a necessary step in the clinical management of patients with schizophrenia due to different reasons including insufficient response and poor tolerability This is an open-label non-randomized study of a formulation of risperidone RISPERDAL CONSTA coated microspheres injected into the muscle at week intervals over 6 months in patients with schizophrenia or schizoaffective disorder During the first 3 weeks oral olanzapine treatment is continued to provide therapy until the risperidone long-acting injectable reaches effective drug levels The oral olanzapine treatment is tapered off within 1 week for one group of patients and within 3 weeks for another group Assessments of effectiveness include the Positive and Negative Syndrome Scale PANSS overall severity of illness measured by the Clinical Global Impression CGI scale and quality of life evaluated by the SF-36 questionnaire Safety evaluations include incidence of adverse events through out the study and Extrapyramidal Symptom Rating Scale ESRS clinical laboratory tests biochemistry hematology and urinalysis and physical exams including body weight at specified intervals The study hypothesis is that changing to treatment every 2 weeks with long-acting risperidone will provide a maintained effectiveness patients with schizophrenia or schizoaffective disorder and will be generally well-tolerated Risperidone long-acting formulation for intramuscular injection 25 milligramsmg every 2 weeks for 6 months Investigator may adjust dosage to 375mg or 50mg maximum or supplement risperidone injections with risperidone tablets 2mg maximum according to symptoms and treatment response
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