To Determine if Olanzapine is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia
- Conditions
- Schizoaffective DisorderSchizophrenia
- Interventions
- Registration Number
- NCT00007774
- Lead Sponsor
- US Department of Veterans Affairs
- 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 mg/day), haloperidol (5 mg to 20 mg/day).
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, ECG?s).
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 mg/day to 20 mg/day. The other treatment group was prescribed haloperidol with daily dosage also ranging from 5 mg/day to 20 mg/day. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
Patients with schizophrenia or schizoaffective disorder.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Olanzapine Olanzapine 2 Haloperidol Haloperidol
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
VA Medical Center, Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
VA Pittsburgh Health Care System
🇺🇸Pittsburgh, Pennsylvania, United States
VA Medical Center, Bay Pines
🇺🇸Bay Pines, Florida, United States
VA Medical Center, Miami
🇺🇸Miami, Florida, United States
VA Medical Center, Cleveland
🇺🇸Cleveland, Ohio, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
VA Maryland HCS, Perry Point Division
🇺🇸Perry Point, Maryland, United States
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
🇺🇸Bedford, Massachusetts, United States
Richard Roudebush VA Medical Center, Indianapolis
🇺🇸Indianapolis, Indiana, United States
VA Medical Center, Augusta
🇺🇸Augusta, Georgia, United States
New York Harbor HCS
🇺🇸New York, New York, United States
John D. Dingell VA Medical Center, Detroit
🇺🇸Detroit, Michigan, United States
VA Medical Center, Tuscaloosa
🇺🇸Tuscaloosa, Alabama, United States
Franklin Delano Roosevelt Campus, VA Hudson Valley HCS
🇺🇸Montrose, New York, United States
VA Connecticut Health Care System (West Haven)
🇺🇸West Haven, Connecticut, United States
VA New Jersey Health Care System, East Orange
🇺🇸East Orange, New Jersey, United States
New Mexico VA Health Care System, Albuquerque
🇺🇸Albuquerque, New Mexico, United States
VA Medical Center, Durham
🇺🇸Durham, North Carolina, United States