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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 |
---|---|---|
Schizophrenia Schizoaffective Disorder |
Drug: Olanzapine (5 mg to 20 mg/day Drug: Haloperidol (5 mg to 20 mg/day) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | CSP #451 - The Clinical and Economic Impact of Olanzapine in the Traetment of Schizophrenia |
Estimated Enrollment: | 600 |
Study Start Date: | March 1998 |
Estimated Study Completion Date: | June 2001 |
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 |
Patients with schizophrenia or schizoaffective disorder.
United States, Alabama | |
Vamc - Tuscaloosa, Al | |
Tuscaloosa, Alabama, United States, 35404 | |
Vamc - Tuskegee, Al | |
Tuskegee, Alabama, United States, 36093 | |
United States, California | |
Vamc - Palo Alto, Ca | |
Palo Alto, California, United States, 94304 | |
United States, Connecticut | |
Vamc - West Haven,Ct | |
West Haven, Connecticut, United States, 06516 | |
United States, Florida | |
Vamc - Bay Pines, Fl | |
Bay Pines, Florida, United States, 33744 | |
Vamc - Miami, Fl | |
Miami, Florida, United States, 33125 | |
United States, Georgia | |
Vamc - Augusta, Ga | |
Augusta, Georgia, United States, 30904-6285 | |
United States, Indiana | |
Vamc - Indianapolis, in | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Vamc - Perry Point, Md | |
Perry Point, Maryland, United States, 21902 | |
United States, Massachusetts | |
Vamc - Bedford, Ma | |
Bedford, Massachusetts, United States, 01730 | |
United States, Michigan | |
Vamc - Detroit, Mi | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
New Jersey Hcs - Lyons, Nj | |
Lyons, New Jersey, United States, 07939 | |
United States, New Mexico | |
VAMC - Albuquerque, NM | |
Albuquerque, New Mexico, United States, 87108 | |
United States, New York | |
Vamc - Montrose, Ny | |
Montrose, New York, United States, 10548-0100 | |
Vamc - New York, Ny | |
New York, New York, United States, 10010 | |
United States, North Carolina | |
Vamc - Durham, Nc | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
Vamc - Brecksville, Oh | |
Brecksville, Ohio, United States, 44141 | |
United States, Pennsylvania | |
Vamc - Philadelphia, Pa | |
Philadelphia, Pennsylvania, United States, 19104 | |
Vamc - Pittsburgh, Pa | |
Pittsburgh, Pennsylvania, United States, 15206-1297 |
Study ID Numbers: | 451 |
Study First Received: | December 29, 2000 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00007774 |
Health Authority: | United States: Food and Drug Administration |
Olanzapine, haloperidol, schizophrenia, schisoaffective disorder |
Haloperidol Schizophrenia Haloperidol decanoate Dopamine Mental Disorders |
Olanzapine Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants |
Dopamine Antagonists Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |