Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249119
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 in Patients With Chronic Schizophrenia
Sponsor:
Janssen LP
Organization:
Janssen LP
Study Overview
Official Title:
Risperidone in the Treatment of Chronic Schizophrenic Patients an International Multicentre Double-blind Parallel-group Comparative Study Versus Haloperidol
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 a fixed 10-mg 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 five dosages of risperidone 1 4 8 12 or 16 mg per day compared with a fixed dose of a standard antipsychotic haloperidol 10 mg per day in patients with chronic schizophrenia 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 and 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 percent of patients showing clinical improvement on the Positive and Negative Syndrome Scale for Schizophrenia PANSS and the average total PANSS score from baseline to the 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 urinalysis and hormone levels 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 doses of 4 8 12 or 16 mgday are more effective than risperidone 10 mgday as measured by clinical improvement on PANSS and the average total score for PANSS in patients with chronic schizophrenia Risperidone oral tablets twice-daily starting with 1 or 2 mgday increasing gradually in Week 1 except for 1 mgday group then 05 2 4 6 or 8 mg twice daily for 7 weeks Haloperidol oral tablets twice-daily starting with 2 mgday increasing to 5 mg twice daily in Week 1 then 5 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