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	Treatment or Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Olanzapine (5 mg to 20 mg/day  Drug: Haloperidol (5 mg to 20 mg/day)	Phase IV

Further Study Details: 

Expected Total Enrollment:  600

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.

Genders Eligible for Study:  Both

Criteria

Patients with schizophrenia or schizoaffective disorder.

Alabama
      Vamc - Tuscaloosa, Al, Tuscaloosa,  Alabama,  35404,  United States
California
      Vamc - Palo Alto, Ca, Palo Alto,  California,  94304,  United States
Connecticut
      Vamc - West Haven,Ct, West Haven,  Connecticut,  06516,  United States
Florida
      Vamc - Bay Pines, Fl, Bay Pines,  Florida,  33744,  United States
      Vamc - Miami, Fl, Miami,  Florida,  33125,  United States
Georgia
      Vamc - Augusta, Ga, Augusta,  Georgia,  30904-6285,  United States
Indiana
      Vamc - Indianapolis, in, Indianapolis,  Indiana,  46202,  United States
Massachusetts
      Vamc - Bedford, Ma, Bedford,  Massachusetts,  01730,  United States
Michigan
      Vamc - Detroit, Mi, Detroit,  Michigan,  48201,  United States
      Vamc - Detroit, Mi, Detroit,  Michigan,  48201,  United States
New Jersey
      New Jersey Hcs - Lyons, Nj, Lyons,  New Jersey,  07939,  United States
New Mexico
      VAMC - Albuquerque, NM, Albuquerque,  New Mexico,  87108,  United States
New York
      Vamc - Montrose, Ny, Montrose,  New York,  10548-0100,  United States
      Vamc - New York, Ny, New York,  New York,  10010,  United States
North Carolina
      Vamc - Durham, Nc, Durham,  North Carolina,  27705,  United States
Ohio
      Vamc - Brecksville, Oh, Brecksville,  Ohio,  44141,  United States
Pennsylvania
      Vamc - Philadelphia, Pa, Philadelphia,  Pennsylvania,  19104,  United States
      Vamc - Pittsburgh, Pa, Pittsburgh,  Pennsylvania,  15206-1297,  United States

Study ID Numbers:  451
Record last reviewed:  February 2003
Last Updated:  October 13, 2004
Record first received:  December 29, 2000
ClinicalTrials.gov Identifier:  NCT00007774
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08