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To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia Clinical research trials and To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia. To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia  To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia
To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia
For Condition: Schizoaffective Disorder,Schizophrenia
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program,Eli Lilly and Company
Synopsis: 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.
Details: 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 will be followed for one year. 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients with schizophrenia or schizoaffective disorder.
Total Enrollment: 600
Location and Contact Information:
Vamc - Tuscaloosa, Al
Tuscallosa, Alabama, 35404
United States
Vamc - Pittsburgh, Pa
Pittsburgh, Pennsylvania, 15206-1297
United States
Vamc - Detroit, Mi
Detroit, Michigan, 48201
United States
New Jersey Hcs - Lyons, Nj
Lyons, New Jersey, 07939
United States
VAMC - Albuquerque, NM
Albuquerque, New Mexico, 87108
United States
Vamc - West Haven,Ct
West Haven, Connecticut, 06516
United States
Vamc - Bedford, Ma
Bedford, Massachusetts, 01730
United States
Vamc - Detroit, Mi
Detroit, Michigan, 48201
United States
Vamc - Augusta, Ga
Augusta, Georgia, 30904-6285
United States
Vamc - New York, Ny
New York City, New York, 10010
United States
Vamc - Montrose, Ny
Montrose, New York, 10548-0100
United States
Vamc - Philadelphia, Pa
Philadelphia, Pennsylvania, 19104
United States
Vamc - Miami, Fl
Miami, Florida, 33125
United States
Vamc - Durham, Nc
Durham, North Carolina, 27705
United States
Vamc - Indianapolis, in
Indianapolis, Indiana, 46202
United States
Vamc - Brecksville, Oh
Brecksville, Ohio, 44141
United States
Vamc - Palo Alto, Ca
Palo Alto, California, 94304
United States
Vamc - Bay Pines, Fl
Bay Pines, Florida, 33744
United States
Additional Information:
Study ID Numbers: 451;
Study Start Date: June 1998
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007774
Other Schizophrenia Studies:
1. Medication Adherence in Older People with Psychosis
2. Imaging of Brain Receptors in Healthy Volunteers and in Patients with Schizophrenia
3. Clinical Study of Schizophrenia
4. Magnetic Resonance Imaging (MRI) of Neuropsychiatric Patients and Healthy Volunteers
5. Evaluation of the Genetics of Bipolar Disorder
Related Studies:
Other Schizophrenia Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia
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