Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00253136
Status:
COMPLETED
Last Update Posted:
2010-12-03
First Post:
2005-11-10
Brief Title:
A Study of the Effectiveness and Safety of Long-acting Injectable Risperidone Versus Placebo in the Treatment of Patients With Schizophrenia
Sponsor:
Janssen LP
Organization:
Janssen LP
Study Overview
Official Title:
Risperidone Depot Microspheres vs Placebo in the Treatment of Subjects With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2010-12
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 the study is to compare the effectiveness and safety of a long-acting injectable formulation of risperidone an antipsychotic medication versus placebo for the treatment of the symptoms of schizophrenia over a 12-week period
Detailed Description:
Schizophrenia is a severe mental illness that causes changes in a persons perception thoughts and behaviour In schizophrenics the most common symptoms are positive symptoms delusions and hallucinations negative symptoms avoiding social situations lack of feeling or expression and disorganized symptoms confusion in thinking and speech Because of the serious nature of these diseases it is important that patients with schizophrenia 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 placebo-controlled study comparing the effectiveness and safety of an injectable formulation of risperidone coated microspheres to placebo in patients with schizophrenia The study is composed of two periods a 1-week run-in period patients discontinue other antipsychotic drugs and receive oral risperidone up to 4 mgday and a 12 week double-blind period during which subjects are randomized to receive bi-weekly injections of placebo or risperidone long-acting injectable formulation 25 50 or 75 mg During the first 3 weeks of double-blind treatment patients will receive supplemental daily oral doses of placebo or risperidone 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 The PANSS is a rating scale that measures the symptoms of schizophrenia 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 Additional testing conducted includes the Clinical Global Impressions CGI a rating system used to evaluate the overall and severity of clinical change in a patient with various diseases affecting the brain and the SF-36 Health Survey a questionnaire the patient fills out that is extensively used to rate a patients quality of life The study hypothesis is that the injectable form of risperidone will be more effective than placebo as measured by the change from baseline in the total PANSS score in patients with schizophrenia 1-week run-in period risperidone oral tablets up to 4 mgday During the first 3 weeks of double-blind period risperidone oral tablets 2 4 or 6 mgday or placebo tablets Day 1 of double-blind period and every 2 weeks thereafter risperidone intramuscular injection 25 50 or 75 mg or placebo injection for 12 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