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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

Page last updated: August 23, 2015

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