Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257023
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-11-18
Brief Title:
An Exploratory Study on the Safety and Effectiveness of Paliperidone in Patients With Schizophrenia
Sponsor:
Janssen Pharmaceutical KK
Organization:
Janssen Pharmaceutical KK
Study Overview
Official Title:
Exploratory Study of Paliperidone in Patients With Schizophrenia to Investigate the Safety and Efficacy
Status:
COMPLETED
Status Verified Date:
2011-01
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 this study is to assess the safety effectiveness and plasma concentration of paliperidone an antipsychotic medication given once daily in the treatment of patients with schizophrenia
Detailed Description:
Paliperidone is an extended-release tablet Paliperidone is an active metabolite of risperidone not approved for the treatment of schizophrenia in Japan This is a multicenter open-label parallel-group fixed dose study to evaluate the safety effectiveness and plasma concentration of paliperidone taken once daily in patients with schizophrenia The patients will receive a fixed dose of paliperidone 3 9 and 15 mg for 6 weeks and its effectiveness and safety will be observed for an additional 2 weeks Efficacy will be measured by determining changes throughout the study in the Positive and Negative Syndrome Scale PANSS score a scale for the measurement of symptoms of schizophrenia and the Clinical Global Impression CGI score In addition the study also assesses the relationship between doseplasma drug concentration and dopamine D2 receptor occupancy in patients who consent to receive positron emission tomography PET Safety evaluations symptoms physical exams electrocardiograms laboratory tests Drug-Induced Extrapyramidal Symptoms Scale DIESS results and adverse event monitoring will be conducted throughout the study The study hypothesis is that paliperidone will be effective in the treatment of schizophrenia and that it will be well-tolerated The patients will receive either 3 9 or 15 mg of paliperidone taken once daily by mouth for 6 weeks
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