Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210548
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-13
Brief Title:
A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel-Group Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses 50 mg eq 100 mg eq and 150 mg eq of Paliperidone Palmitate in Subjects With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2010-04
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 evaluate the effectiveness and safety of 3 doses of paliperidone palmitate in treating subjects with schizophrenia
Detailed Description:
This is a randomized double-blind placebo-controlled parallel-group multicenter dose-response study of patients who have a Diagnostic and Statistical Manual of Mental Disorders 4th edition DSM IV diagnosis of schizophrenia The duration of the study is approximately 14 weeks including a screening period of 1 week and a 13-week double-blind treatment period Efficacy and safety will be evaluated periodically throughout the study Samples for pharmacokinetic evaluation will be collected at designated time points and a blood sample will be collected at baseline before the start of double-blind treatment for an optional pharmacogenomics genetics analysis The hypothesis is that the 3 fixed doses of paliperidone are each more efficacious than placebo in treating subjects with schizophrenia The effectiveness is measured primarily by the change in the Positive and Negative Syndrome Scale for Schizophrenia PANSS and secondarily by the investigators Clinical Global Impression of Severity CGI-S and by the investigators evaluation of the patient on a Personal and Social Performance PSP Scale Four injections of paliperidone palmitate 50 100 or 150 milligrams equivalent administered in the gluteal muscle buttocks Injections will be given on Days 1 8 36 and 64 of the double-blind treatment period of the study
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