Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007774
Status:
COMPLETED
Last Update Posted:
2009-02-04
First Post:
2000-12-29
Brief Title:
To Determine if Olanzapine is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 451 - The Clinical and Economic Impact of Olanzapine in the Treatment of Schizophrenia
Status:
COMPLETED
Status Verified Date:
2009-02
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:
Although currently marketed antipsychotic drugs are useful in the treatment of schizophrenia efficacy and safety profiles need to be improved Forty to eighty percent of patients either fail to respond or only partially respond to conventional antipsychotic agents Secondary symptoms may be unimproved even in patients who respond to treatment A variety of adverse events occur in patients receiving currently available agents The severity of these events contributes to the poor compliance that is observed in this patient population Olanzapine is a novel antipsychotic agent with a reduced incidence of extrapyramidal symptoms Other side effects are minimal
Detailed Description:
Primary Hypothesis To determine if olanzapine is more cost effective than haloperidol for the treatment of schizophrenia
Secondary Hypothesis Secondary objectives include evaluation of clinical efficacy safety social and vocational functioning family burden compliance and satisfaction for olanzapine relative to haloperidol
Intervention Olanzapine 5 mg to 20 mgday haloperidol 5 mg to 20 mgday
Primary Outcomes Total inpatient hospital care costs are the primary outcome Other major outcomes are total social costs cost of VA health care non-VA services and other specified social costs efficacy measures PANNS BPRS CGI Severity and neurocognitive battery scores and safety measures adverse events ECGs
Study Abstract Although currently marketed antipsychotic drugs are useful in the treatment of schizophrenia efficacy and safety profiles need to be improved Forty to eighty percent of patients either fail to respond or only partially respond to conventional antipsychotic agents Secondary symptoms may be unimproved even in patients who respond to treatment A variety of adverse events occur in patients receiving currently available agents The severity of these events contributes to the poor compliance that is observed in this patient population Olanzapine is a novel antipsychotic agent with a reduced incidence of extrapyramidal symptoms Other side effects are minimal
Approximately 327 patients with schizophrenia or schizoaffective disorder were randomly assigned to one of two treatment groups One treatment group was prescribed olanzapine with daily dosage ranging from 5 mgday to 20 mgday The other treatment group was prescribed haloperidol with daily dosage also ranging from 5 mgday to 20 mgday A semi-structured psychosocial case management treatment program is provided for all study patients Patients were recruited from 18 VA medical centers over a 24-month period and were followed for one year 18 patients were enrolled at one site that had its research program terminated during the study Because of questions regarding the circumstances that led to the termination these 18 patients will not be included in study analyses The major objective of the study is to determine if olanzapine is more cost effective than haloperidol Secondary objectives include evaluation of clinical efficacy safety social and vocational functioning family burden compliance and satisfaction for olanzapine relative to haloperidol
MANUSCRIPT Primary manuscript published in JAMA November 2003
Secondary Hypothesis Secondary objectives include evaluation of clinical efficacy safety social and vocational functioning family burden compliance and satisfaction for olanzapine relative to haloperidol
Intervention Olanzapine 5 mg to 20 mgday haloperidol 5 mg to 20 mgday
Primary Outcomes Total inpatient hospital care costs are the primary outcome Other major outcomes are total social costs cost of VA health care non-VA services and other specified social costs efficacy measures PANNS BPRS CGI Severity and neurocognitive battery scores and safety measures adverse events ECGs
Study Abstract Although currently marketed antipsychotic drugs are useful in the treatment of schizophrenia efficacy and safety profiles need to be improved Forty to eighty percent of patients either fail to respond or only partially respond to conventional antipsychotic agents Secondary symptoms may be unimproved even in patients who respond to treatment A variety of adverse events occur in patients receiving currently available agents The severity of these events contributes to the poor compliance that is observed in this patient population Olanzapine is a novel antipsychotic agent with a reduced incidence of extrapyramidal symptoms Other side effects are minimal
Approximately 327 patients with schizophrenia or schizoaffective disorder were randomly assigned to one of two treatment groups One treatment group was prescribed olanzapine with daily dosage ranging from 5 mgday to 20 mgday The other treatment group was prescribed haloperidol with daily dosage also ranging from 5 mgday to 20 mgday A semi-structured psychosocial case management treatment program is provided for all study patients Patients were recruited from 18 VA medical centers over a 24-month period and were followed for one year 18 patients were enrolled at one site that had its research program terminated during the study Because of questions regarding the circumstances that led to the termination these 18 patients will not be included in study analyses The major objective of the study is to determine if olanzapine is more cost effective than haloperidol Secondary objectives include evaluation of clinical efficacy safety social and vocational functioning family burden compliance and satisfaction for olanzapine relative to haloperidol
MANUSCRIPT Primary manuscript published in JAMA November 2003
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