Effectiveness and Cost of Olanzapine and Haloperidol in the Treatment of Schizophrenia: A Randomized Controlled Trial

Robert Rosenheck, Deborah Perlick, Stephen Bingham, Wen Liu-Mares, Joseph Collins, Stuart Warren, Douglas Leslie, Edward Allan, E. Cabrina Campbell, Stanley Caroff, June Corwin, Lori Davis, Richard Douyon, Lawrence Dunn, Denise Evans, Ede Frecska, John Grabowski, David Graeber, Lawrence Herz, Kong KwonWilliam Lawson, Felicitas Mena, Javaid Sheikh, David Smelson, Valerie Smith-Gamble

Research output: Contribution to journalArticlepeer-review

319 Scopus citations


Context: Although olanzapine has been widely adopted as a treatment of choice for schizophrenia, its long-term effectiveness and costs have not been evaluated in a controlled trial in comparison with a standard antipsychotic drug. Objective: To evaluate the effectiveness and cost impact of olanzapine compared with haloperidol in the treatment of schizophrenia. Design and Setting: Double-blind, randomized controlled trial with randomization conducted between June 1998 and June 2000 at 17 US Department of Veterans Affairs medical centers. Participants: Three hundred nine patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of schizophrenia or schizoaffective disorder, serious symptoms, and serious dysfunction for the previous 2 years. Fifty-nine percent fully completed and 36% partially completed follow-up assessments. Interventions: Patients were randomly assigned to receive flexibly dosed olanzapine, 5 to 20 mg/d, with prophylactic benztropine, 1 to 4 mg/d (n = 159); or haloperidol, 5 to 20 mg/d (n=150), for 12 months. Main Outcome Measures: Standardized measures of symptoms, quality of life, neurocognitive status, and adverse effects of medication. Veterans Affairs administrative data and interviews concerning non-VA service use were used to estimate costs from the perspective of the VA health care system and society as a whole (ie, consumption of all resources on behalf of these patients). Results: There were no significant differences between groups in study retention; positive, negative, or total symptoms of schizophrenia; quality of life; or extrapyramidal symptoms. Olanzapine was associated with reduced akathisia in the intention-to-treat analysis (P<.001) and with lower symptoms of tardive dyskinesia in a secondary analysis including only observations during blinded treatment with study drug. Small but significant advantages were also observed on measures of memory and motor function. Olanzapine was also associated with more frequent reports of weight gain and significantly greater VA costs, ranging from $3000 to $9000 annually. Differences in societal costs were somewhat smaller and were not significant. Conclusion: Olanzapine does not demonstrate advantages compared with haloperidol (in combination with prophylactic benztropine) in compliance, symptoms, extrapyramidal symptoms, or overall quality of life, and its benefits in reducing akathisia and improving cognition must be balanced with the problems of weight gain and higher cost.

Original languageEnglish (US)
Pages (from-to)2693-2702
Number of pages10
Issue number20
StatePublished - Nov 26 2003

All Science Journal Classification (ASJC) codes

  • General Medicine


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