Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216671
Status:
COMPLETED
Last Update Posted:
2013-07-19
First Post:
2005-09-13
Brief Title:
Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
Early Versus Late Initiation of Treatment With Risperdal Consta in Subjects With Schizophrenia After an Acute Episode
Status:
COMPLETED
Status Verified Date:
2013-07
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 primary objective of this randomized trial was to investigate whether early initiation of treatment with Risperdal Consta after an acute episode was not inferior to the routine approach oral treatment for 12 weeks followed by treatment with Risperdal Consta
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 regiment Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen Traditionally patients experiencing an episode of schizophrenia are first treated with oral medications until they are stabilized and then injectable long-acting formulations are given This is an open multicenter randomized Phase IV trial in patients after an acute episode of schizophrenia Patients will be in the trial for 6 months One treatment group will receive injections starting at baseline early initiation the other group will start with treatment as usual at baseline and begin injections at Week 12 late initiation Assessment of effectiveness include Positive And Negative Syndrome Scale PANSS in order to measure symptoms of schizophrenia Clinical Global Impression - Severity CGI-S measuring overall severity of illness Global Assessment of Functioning GAF assessesing overall psychological social and occupational functioning and Quality of Life Questionnaire SF-12 measuring overall health status Safety evaluations include the Extrapyramidal Symptoms Rating Scale ESRS incidence of adverse events throughout the study and vital signs pulse blood pressure The study hypothesis is that early initiation of long-acting risperidone injections is not inferior to late initiation as measured by changes in PANSS total score from baseline through endpoint after 6 months Risperidone long-acting formulation for intramuscular injections 25 to 50 mg maximum given every 14 days through 6 months starting at baseline or Month 3 Treatment as usual for 3 months for late initiation group
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