Quality of Life in Schizophrenia: A Multicenter, Randomized, Naturalistic, Controlled Trial Comparing Olanzapine to First-Generation Antipsychotics

Maurício Silva de Lima, M.D., Ph.D.; Jair de Jesus Mari, M.D., Ph.D.; Alan Breier, M.D.; Anna Maria Costa, M.D., Ph.D.; Eduardo Pondé de Sena, M.D., M.Sc.; and Matthew Hotopf, M.D., Ph.D.

Objective: To assess the effectiveness of olanzapine for treating schizophrenia and to assess if olanzapine promotes a better quality of life than first-generation antipsychotics (FGAs).

Method: Multicenter, naturalistic, randomized controlled study, comparing olanzapine with FGAs, at hospitalization and during a 9-month follow-up. Outcome assessors were blind to the allocated drug. The dose of antipsychotic was determined by doctors according to their clinical practice routines. Data collection was performed from April 1999 to August 2001.

Results: 197 patients with DSM-IV-diagnosed schizophrenia were allocated to olanzapine (N = 104) and FGA (N = 93). Patients taking olanzapine showed greater improvements in Positive and Negative Syndrome Scale (PANSS) negative symptoms (mean difference = 2.3, 95% CI = 0.6 to 4.1) and general psychopathology (mean difference = 4.0, 95% CI = 0.8 to 7.2) subscales and fewer incidences of tardive dyskinesia (RR = 2.4, 95% CI = 1.4 to 4.2, p < .0001). Olanzapine was also associated with greater improvement in a number of health-related quality-of-life outcomes on the Medical Outcomes Study 36-item Short-Form Health Survey, including physical functioning (mean difference = 6.6, 95% CI = 1.2 to 11.9), physical role limitations (mean difference = 13.7, 95% CI = 3.0 to 24.3), and emotional role limitations (mean difference = 12.1, 95% CI = 0.7 to 23.5). Patients taking olanzapine gained significantly more weight during the trial than patients taking FGAs, with a correspondent endpoint increase in the body mass index (BMI) of 28.7 versus 25.3 (p < .001).

Conclusion: Compared with FGAs, olanzapine has advantages in terms of improvements of negative symptoms and quality of life. It is also associated with fewer incidences of tardive dyskinesia and greater increases in weight and BMI. These findings are highlighted by the naturalistic approach adopted in this trial.

(J Clin Psychiatry 2005;66:831-838)

Received Sept. 20, 2004; accepted Dec. 1, 2004. From Eli Lilly Brazil, São Paulo, Brazil (Drs. de Lima and Costa); the Federal University of Pelotas and Catholic University of Pelotas, Pelotas, Brazil (Dr. de Lima); Department of Psychiatry, Federal University of São Paulo, São Paulo, and Catholic University of Pelotas, Pelotas, Brazil (Dr. Mari); Eli Lilly and Company, Indianapolis, Ind. (Dr. Breier); Department of Psychiatry, Federal University of São Paulo, São Paulo, Brazil (Dr. Costa); Department of Pharmacology, Federal University of Bahia, Salvador, Brazil (Dr. de Sena); and Guy's King's and St. Thomas' School of Medicine and Institute of Psychiatry, King's College, London, United Kingdom (Dr. Hotopf). Dr. Costa is now with Bristol-Myers Squibb Brazil, São Paulo, Brazil.

This study was funded by Eli Lilly Brazil, São Paulo, Brazil.

Presented at the 156th meeting of the American Psychiatric Association in San Francisco, Calif., 2003, as a poster, and at the 27th annual meeting of the Nordic Psychiatric Congress in Reykjavik, 2003.

Dr. Mari has received grant/research support from Eli Lilly Brazil. Dr. de Sena has participated in speakers/advisory boards for Eli Lilly Brazil. Drs. de Lima, Breier, Costa, and Hotopf report no other affiliation or financial relationship relevant to the article.

Corresponding author and reprints: Maurício Silva de Lima, M.D., Ph.D., Federal University of Pelotas and Catholic University of Pelotas, Av. Duque de Caxias, 250. Pelotas, RS-Brazil (e-mail: limama@lilly.com).