Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00253110
Status:
COMPLETED
Last Update Posted:
2012-08-06
First Post:
2005-11-10
Brief Title:
A Comparison of Risperidone With Haloperidol in Patients With Schizophrenia and Schizoaffective Disorder
Sponsor:
Janssen LP
Organization:
Janssen LP
Study Overview
Official Title:
A Comparison of Risperidone and Haloperidol for Prevention of Relapse in Subjects With Schizophrenia and Schizoaffective Disorders
Status:
COMPLETED
Status Verified Date:
2012-08
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 time to relapse in patients with schizophrenia and schizoaffective disorders receiving risperidone or haloperidol antipsychotic medications for at least 1 year
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 Schizoaffective disorder is different from schizophrenia although it may be misdiagnosed as this illness Schizoaffective disorder is a mental illness distinguished by a combination of a thought disorder abnormal thinking or psychotic symptoms such as hallucinations or delusions and a mood disorder clinical depression or manic component Manic symptoms include but are not limited to an overinflated self esteem increased physical agitation excessively poor judgment being easily distracted and an increased irritability and energy level This is a randomized double-blind parallel-group controlled study comparing the time to relapse and the incidence of relapse in patients with schizophrenia and schizoaffective disorder being treated with risperidone or haloperidol The long-term safety and effectiveness of risperidone and haloperidol are also compared The study is composed of two phases a 1-week baseline period and a double-blind treatment period During the baseline period the doses of risperidone and haloperidol are gradually increased to 4 mgday for risperidone and 10 mgday for haloperidol During the first 4 weeks of double-blind treatment dosage adjustments can be made in the range of 2 - 8 mgday for risperidone and 5 - 20 mgday for haloperidol based on clinical evaluations of the patient The double-blind treatment continues at that dose until the last patient entering the study completes 1 year of treatment or for a maximum of 112 weeks The primary measure of effectiveness is the time to relapse which is defined using six criteria that indicate the patients illness is no longer under control for example psychiatric hospitalization Additional efficacy testing conducted includes the Positive and Negative Syndrome Scale for Schizophrenia PANSS a rating scale that measures the symptoms of schizophrenia 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 Quality of Life Interview QOLI a global measure of satisfaction with life 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 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 will be more effective in delaying relapse than haloperidol in patients with schizophrenia and schizoaffective disorder Risperidone tablets taken orally starting at 1 mgday increasing to 4 mgday Week 1 Haloperidol tablets taken orally starting at 2 mgday increasing to 10 mgday Week 1 After Week 1 dosage may be adjusted 2 - 8 mgday risperidone 5 - 20 mgday haloperidol Treatment duration 52 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RIS-USA-79 | OTHER | Janssen LP | None |