To Determine if Olanzapine is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia
Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizoaffective Disorder; Schizophrenia
Intervention: Haloperidol (Drug); Olanzapine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Robert A. Rosenheck, AB MD, Study Chair, Affiliation: VA Connecticut Health Care System (West Haven)
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.
Clinical Details
Official title: CSP #451 - The Clinical and Economic Impact of Olanzapine in the Treatment of Schizophrenia
Study design: Masking: Double-Blind
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Patients with schizophrenia or schizoaffective disorder.
Exclusion Criteria:
Locations and Contacts
VA Medical Center, Tuscaloosa, Tuscaloosa, Alabama 35404, United States
VA Palo Alto Health Care System, Palo Alto, California 94304-1290, United States
VA Connecticut Health Care System (West Haven), West Haven, Connecticut 06516, United States
VA Medical Center, Bay Pines, Bay Pines, Florida 33708, United States
VA Medical Center, Miami, Miami, Florida 33125, United States
VA Medical Center, Augusta, Augusta, Georgia 30904, United States
Richard Roudebush VA Medical Center, Indianapolis, Indianapolis, Indiana 46202-2884, United States
VA Maryland HCS, Perry Point Division, Perry Point, Maryland 21902, United States
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Bedford, Massachusetts 01730, United States
John D. Dingell VA Medical Center, Detroit, Detroit, Michigan 48201, United States
VA New Jersey Health Care System, East Orange, East Orange, New Jersey 07018, United States
New Mexico VA Health Care System, Albuquerque, Albuquerque, New Mexico 87108-5153, United States
Franklin Delano Roosevelt Campus, VA Hudson Valley HCS, Montrose, New York 10548, United States
New York Harbor HCS, New York, New York 10010, United States
VA Medical Center, Durham, Durham, North Carolina 27705, United States
VA Medical Center, Cleveland, Cleveland, Ohio 44106, United States
VA Medical Center, Philadelphia, Philadelphia, Pennsylvania 19104, United States
VA Pittsburgh Health Care System, Pittsburgh, Pennsylvania 15240, United States
Additional Information
Starting date: March 1998
Last updated: February 3, 2009
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