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To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia conditions. Clinical Trials Search.org is a website dedicated 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 medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including 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 permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid 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. Participants oftentimes recieve the finest healthcare available for their To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.

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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 Schizoaffective Disorder Studies:
1. A Study of Galantamine as an Adjunctive Treatment to Atypical Antipsychotics in Schizophrenia Patients with Cognitive Deficits

2. 3 Fixed Dosages of Extended Release OROS Paliperidone and Olanzapine in the Treatment of Subjects with Schizophrenia

3. Inpatient Evaluation of Adults with Schizophrenia

4. Improving Antipsychotic Adherence Among Patients with Schizophrenia

5. Switching Medication to Treat Schizophrenia

Related Studies:

Other Schizoaffective Disorder Clinical Trials
Other Connecticut Clinical Trials
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To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia

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