Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249132
Status:
COMPLETED
Last Update Posted:
2011-02-11
First Post:
2005-11-04
Brief Title:
A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol and Placebo in Patients With Chronic Schizophrenia
Sponsor:
Janssen LP
Organization:
Janssen LP
Study Overview
Official Title:
Risperidone Versus Haloperidol Versus Placebo in the Treatment of Chronic Schizophrenia
Status:
COMPLETED
Status Verified Date:
2011-02
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 the study is to evaluate the effectiveness and safety of different doses of risperidone an antipsychotic medication compared with placebo and with a fixed 20 mgday dose of a standard antipsychotic haloperidol 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 This is a randomized double-blind parallel-group study to evaluate the effectiveness and safety of four dosages of risperidone 2 6 10 or 16 mgday compared with placebo and with a fixed 20 mgday dose of a standard antipsychotic haloperidol in patients with chronic schizophrenia who are in-patients at the beginning of the study
The study is composed of two phases a 1-week period in which patients receive placebo and all current medication for schizophrenia treatment is stopped followed by a double-blind treatment phase The doses of study drug are increased progressively during the first week of the double-blind period and then remain constant for the next 7 weeks The primary measures of effectiveness are the percentage of patients showing clinical improvement reduction of 20 from baseline on the Positive and Negative Syndrome Scale for Schizophrenia PANSS and the total PANSS score from baseline to end of double-blind treatment 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 and urinalysis plasma levels of risperidone measurements of vital signs and body weight physical examination and electrocardiogram ECG findings neurological examinations 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 risperidone is more effective than placebo as measured by clinical improvement on PANSS and the average total score for PANSS in patients with chronic schizophrenia Risperidone tablets taken orally starting with 1 mg twice daily gradually increasing dose in Week 1 except for 1 mg twice daily group then 1 3 5 or 8 mg twice daily continuing for 7 weeks Haloperidol tablets starting 1 mg twice daily and increasing to 10 mg twice daily Week 1 continuing 10 mg twice daily for 7 weeks
The study is composed of two phases a 1-week period in which patients receive placebo and all current medication for schizophrenia treatment is stopped followed by a double-blind treatment phase The doses of study drug are increased progressively during the first week of the double-blind period and then remain constant for the next 7 weeks The primary measures of effectiveness are the percentage of patients showing clinical improvement reduction of 20 from baseline on the Positive and Negative Syndrome Scale for Schizophrenia PANSS and the total PANSS score from baseline to end of double-blind treatment 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 and urinalysis plasma levels of risperidone measurements of vital signs and body weight physical examination and electrocardiogram ECG findings neurological examinations 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 risperidone is more effective than placebo as measured by clinical improvement on PANSS and the average total score for PANSS in patients with chronic schizophrenia Risperidone tablets taken orally starting with 1 mg twice daily gradually increasing dose in Week 1 except for 1 mg twice daily group then 1 3 5 or 8 mg twice daily continuing for 7 weeks Haloperidol tablets starting 1 mg twice daily and increasing to 10 mg twice daily Week 1 continuing 10 mg twice daily for 7 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