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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007774
• Other study ID #: 451
• Status: Completed
• Phase: Phase 4
• First received: December 29, 2000
• Last updated: February 3, 2009
• Start date: March 1998

Study information

• Verified date: February 2009
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. primary completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients with schizophrenia or schizoaffective disorder.

Exclusion Criteria:

Study Design

Masking: Double-Blind

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Haloperidol

• Olanzapine

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System, Albuquerque	Albuquerque	New Mexico
United States	VA Medical Center, Augusta	Augusta	Georgia
United States	VA Medical Center, Bay Pines	Bay Pines	Florida
United States	Edith Nourse Rogers Memorial Veterans Hospital, Bedford	Bedford	Massachusetts
United States	VA Medical Center, Cleveland	Cleveland	Ohio
United States	John D. Dingell VA Medical Center, Detroit	Detroit	Michigan
United States	VA Medical Center, Durham	Durham	North Carolina
United States	VA New Jersey Health Care System, East Orange	East Orange	New Jersey
United States	Richard Roudebush VA Medical Center, Indianapolis	Indianapolis	Indiana
United States	VA Medical Center, Miami	Miami	Florida
United States	Franklin Delano Roosevelt Campus, VA Hudson Valley HCS	Montrose	New York
United States	New York Harbor HCS	New York	New York
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	VA Maryland HCS, Perry Point Division	Perry Point	Maryland
United States	VA Medical Center, Philadelphia	Philadelphia	Pennsylvania
United States	VA Pittsburgh Health Care System	Pittsburgh	Pennsylvania
United States	VA Medical Center, Tuscaloosa	Tuscaloosa	Alabama
United States	VA Connecticut Health Care System (West Haven)	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (2)

Perlick DA, Rosenheck RA, Kaczynski R, Bingham S, Collins J. Association of symptomatology and cognitive deficits to functional capacity in schizophrenia. Schizophr Res. 2008 Feb;99(1-3):192-9. Epub 2007 Sep 12. — View Citation

Rosenheck R, Perlick D, Bingham S, Liu-Mares W, Collins J, Warren S, Leslie D, Allan E, Campbell EC, Caroff S, Corwin J, Davis L, Douyon R, Dunn L, Evans D, Frecska E, Grabowski J, Graeber D, Herz L, Kwon K, Lawson W, Mena F, Sheikh J, Smelson D, Smith-Ga — View Citation