To Determine if Olanzapine is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia
NCT ID: NCT00007774
Last Updated: 2009-02-04
Study Results
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Basic Information
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COMPLETED
PHASE4
600 participants
INTERVENTIONAL
1998-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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DOUBLE
Study Groups
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1
Olanzapine
Olanzapine
2
Haloperidol
Haloperidol
Interventions
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Haloperidol
Olanzapine
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
US Department of Veterans Affairs
FED
Responsible Party
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Department of Veterans Affairs
Principal Investigators
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Robert A. Rosenheck, AB MD
Role: STUDY_CHAIR
VA Connecticut Health Care System (West Haven)
Locations
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VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States
VA Medical Center, Bay Pines
Bay Pines, Florida, United States
VA Medical Center, Miami
Miami, Florida, United States
VA Medical Center, Augusta
Augusta, Georgia, United States
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States
VA Maryland HCS, Perry Point Division
Perry Point, Maryland, United States
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Bedford, Massachusetts, United States
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, 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
Franklin Delano Roosevelt Campus, VA Hudson Valley HCS
Montrose, New York, United States
New York Harbor HCS
New York, New York, United States
VA Medical Center, Durham
Durham, North Carolina, United States
VA Medical Center, Cleveland
Cleveland, Ohio, United States
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States
Countries
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References
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Perlick DA, Rosenheck RA, Kaczynski R, Bingham S, Collins J. Association of symptomatology and cognitive deficits to functional capacity in schizophrenia. Schizophr Res. 2008 Feb;99(1-3):192-9. doi: 10.1016/j.schres.2007.08.009. Epub 2007 Sep 12.
Rosenheck R, Perlick D, Bingham S, Liu-Mares W, Collins J, Warren S, Leslie D, Allan E, Campbell EC, Caroff S, Corwin J, Davis L, Douyon R, Dunn L, Evans D, Frecska E, Grabowski J, Graeber D, Herz L, Kwon K, Lawson W, Mena F, Sheikh J, Smelson D, Smith-Gamble V; Department of Veterans Affairs Cooperative Study Group on the Cost-Effectiveness of Olanzapine. Effectiveness and cost of olanzapine and haloperidol in the treatment of schizophrenia: a randomized controlled trial. JAMA. 2003 Nov 26;290(20):2693-702. doi: 10.1001/jama.290.20.2693.
Other Identifiers
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451
Identifier Type: -
Identifier Source: org_study_id
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