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Sponsors and Collaborators: |
Department of Veterans Affairs Eli Lilly and Company |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00007774 |
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.
Condition | Intervention | Phase |
---|---|---|
Schizoaffective Disorder Schizophrenia |
Drug: Haloperidol Drug: Olanzapine |
Phase IV |
Study Type: | Interventional |
Study Design: | Double-Blind, Active Control |
Official Title: | CSP #451 - The Clinical and Economic Impact of Olanzapine in the Treatment of Schizophrenia |
Estimated Enrollment: | 600 |
Study Start Date: | March 1998 |
Primary Completion Date: | June 2001 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Olanzapine
|
Drug: Olanzapine |
2: Active Comparator
Haloperidol
|
Drug: Haloperidol |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with schizophrenia or schizoaffective disorder.
Exclusion Criteria:
United States, Alabama | |
VA Medical Center, Tuscaloosa | |
Tuscaloosa, Alabama, United States, 35404 | |
VA Medical Center, Tuscaloosa | |
Tuscaloosa, Alabama, United States, 35404 | |
United States, California | |
VA Palo Alto Health Care System | |
Palo Alto, California, United States, 94304-1290 | |
United States, Connecticut | |
VA Connecticut Health Care System (West Haven) | |
West Haven, Connecticut, United States, 06516 | |
United States, Florida | |
VA Medical Center, Bay Pines | |
Bay Pines, Florida, United States, 33708 | |
VA Medical Center, Miami | |
Miami, Florida, United States, 33125 | |
United States, Georgia | |
VA Medical Center, Augusta | |
Augusta, Georgia, United States, 30904 | |
United States, Indiana | |
Richard Roudebush VA Medical Center, Indianapolis | |
Indianapolis, Indiana, United States, 46202-2884 | |
United States, Maryland | |
VA Maryland HCS, Perry Point Division | |
Perry Point, Maryland, United States, 21902 | |
United States, Massachusetts | |
Edith Nourse Rogers Memorial Veterans Hospital, Bedford | |
Bedford, Massachusetts, United States, 01730 | |
United States, Michigan | |
John D. Dingell VA Medical Center, Detroit | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
VA New Jersey Health Care System, East Orange | |
East Orange, New Jersey, United States, 07018 | |
United States, New Mexico | |
New Mexico VA Health Care System, Albuquerque | |
Albuquerque, New Mexico, United States, 87108-5153 | |
United States, New York | |
Franklin Delano Roosevelt Campus, VA Hudson Valley HCS | |
Montrose, New York, United States, 10548 | |
New York Harbor HCS | |
New York, New York, United States, 10010 | |
United States, North Carolina | |
VA Medical Center, Durham | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
VA Medical Center, Cleveland | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
VA Medical Center, Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
VA Pittsburgh Health Care System | |
Pittsburgh, Pennsylvania, United States, 15240 |
Study Chair: | Robert A. Rosenheck, AB MD | VA Connecticut Health Care System (West Haven) |
Responsible Party: | Department of Veterans Affairs ( Rosenheck, Robert - Study Chair ) |
Study ID Numbers: | 451 |
Study First Received: | December 29, 2000 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00007774 History of Changes |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
Olanzapine, haloperidol, schizophrenia, schisoaffe |
Neurotransmitter Agents Tranquilizing Agents Olanzapine Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents Serotonin Uptake Inhibitors Serotonin |
Schizophrenia Haloperidol Haloperidol decanoate Dopamine Mental Disorders Dopamine Agents Psychotic Disorders Peripheral Nervous System Agents Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Haloperidol Schizophrenia Mental Disorders Therapeutic Uses Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Haloperidol decanoate Serotonin Agents Autonomic Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |