To Determine if Olanzapine is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00007774

Collaborator

Eli Lilly and Company (Industry)

600

Enrollment

Locations

Arms

33.3

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Schizoaffective Disorder Schizophrenia	Drug: Haloperidol Drug: Olanzapine	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Masking:

Double

Official Title:

CSP #451 - The Clinical and Economic Impact of Olanzapine in the Treatment of Schizophrenia

Study Start Date :

Mar 1, 1998

Actual Primary Completion Date :

Jun 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Olanzapine	Drug: Olanzapine
Active Comparator: 2 Haloperidol	Drug: Haloperidol

Arm

Intervention/Treatment

Experimental: 1

Olanzapine

Drug: Olanzapine

Active Comparator: 2

Haloperidol

Drug: Haloperidol

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with schizophrenia or schizoaffective disorder.

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center, Tuscaloosa	Tuscaloosa	Alabama	United States	35404
2	VA Palo Alto Health Care System	Palo Alto	California	United States	94304-1290
3	VA Connecticut Health Care System (West Haven)	West Haven	Connecticut	United States	06516
4	VA Medical Center, Bay Pines	Bay Pines	Florida	United States	33708
5	VA Medical Center, Miami	Miami	Florida	United States	33125
6	VA Medical Center, Augusta	Augusta	Georgia	United States	30904
7	Richard Roudebush VA Medical Center, Indianapolis	Indianapolis	Indiana	United States	46202-2884
8	VA Maryland HCS, Perry Point Division	Perry Point	Maryland	United States	21902
9	Edith Nourse Rogers Memorial Veterans Hospital, Bedford	Bedford	Massachusetts	United States	01730
10	John D. Dingell VA Medical Center, Detroit	Detroit	Michigan	United States	48201
11	VA New Jersey Health Care System, East Orange	East Orange	New Jersey	United States	07018
12	New Mexico VA Health Care System, Albuquerque	Albuquerque	New Mexico	United States	87108-5153
13	Franklin Delano Roosevelt Campus, VA Hudson Valley HCS	Montrose	New York	United States	10548
14	New York Harbor HCS	New York	New York	United States	10010
15	VA Medical Center, Durham	Durham	North Carolina	United States	27705
16	VA Medical Center, Cleveland	Cleveland	Ohio	United States	44106
17	VA Medical Center, Philadelphia	Philadelphia	Pennsylvania	United States	19104
18	VA Pittsburgh Health Care System	Pittsburgh	Pennsylvania	United States	15240