Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249223
Status:
COMPLETED
Last Update Posted:
2011-01-14
First Post:
2005-11-04
Brief Title:
A Comparison of the Effectiveness and Safety of Injectable Risperidone With That of Risperidone Tablets in the Treatment of Patients With Chronic Schizophrenia
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
Risperidone Depot Microspheres vs Risperidone Tablets - a Non-inferiority Efficacy Trial in Subjects With Schizophrenia
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 primary purpose of the study is to show that treatment with an injectable formulation of risperidone is not less effective than and has a similar safety profile to risperidone tablets in patients with chronic schizophrenia
Detailed Description:
Chronic schizophrenia is a longer-term condition that is characterized by a lack of drive underactivity and slowness and social withdrawal As with the acute form of schizophrenia delusions and hallucinations are common Based on the severity and long-term nature of this disease it is important that patients take their antipsychotic medication regularly Long-acting injectable forms of antipsychotic drugs may eliminate the need for daily oral medication and increase a patients compliance in taking their medication as prescribed by their physician This is a randomized double-blind parallel-group study comparing the effectiveness and safety of an injectable formulation of risperidone coated microspheres to risperidone tablets in patients with chronic stable schizophrenia The study is composed of a screening visit followed by two study phases an 8-week run-in period and a 12-week double-blind period In the run-in phase patients discontinue from other antipsychotic drugs begin receiving oral risperidone and stay on the optimal oral risperidone dose that is determined for each patient for 4 weeks before starting the double-blind period Patients are then randomized to either risperidone tablets or the injectable risperidone formulation at the dose level established during the last 4 weeks of run-in For the next 12 weeks patients receive an injection of risperidone every 2 weeks plus daily oral doses of placebo or receive a placebo injection every 2 weeks plus daily oral doses of resperidone tablets The primary measure of effectiveness is the change from baseline in the total score for the Positive and Negative Syndrome Scale for Schizophrenia PANSS a rating scale that measures the symptoms of schizophrenia Additional efficacy testing includes the Clinical Global Impressions CGI a rating system used to evaluate the severity of clinical change in a patient with various diseases affecting the brain Safety evaluations include the incidence of adverse events results of clinical laboratory tests hematology biochemistry urinalysis measurements of vital signs and body weight physical examination and electrocardiogram ECG findings clinical examination of the injection area buttocks and the Extrapyramidal Symptoms Rating Scale ESRS a scale used to measure effects of antipsychotic medications on motor functions of the patient The study hypothesis is that the injectable formulation of risperidone will not be less effective than oral risperidone tablets The injectable formulation of risperidone will be considered less effective than oral risperidone if the improvement in total PANSS with injectable risperidone is more than 6 points worse than the improvement with oral risperidone Risperidone injections 25 50 or 75milligrams mg starting Day 1 of the double-blind phase then every 2 weeks total of 12 weeks or 2 4 or 6mgday risperidone tablets starting Day 1 of the run-in period and continuing for the rest 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