Randomized controlled trial of the effect on quality of life of second- vs first-generation antipsychotic drugs in schizophrenia: cost utility of the latest antipsychotic drugs in schizophrenia study.
Cost Utilization of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1) was funded by the NHS to test the hypothesis that for patients with schizophrenia requiring a change in medication, switching to the more expensive non-clozapine second-generation antipsychotics (SGAs) would be associated with significantly improved quality of life when compared to first-generation antipsychotics (FGAs). They found no significant difference in quality of life, symptoms, or cost, over the course of a year.
- N=227 patients with DSM-IV schizophrenia and related disorders, ages 18-65, who were being assessed for medication review due to inadequate response or adverse effects were randomized to:
- FGA (n=118)
- SGA other than clozapine (n=109)
- Choice of individual drug made by managing psychiatrist.
- Setting: 14 community psychiatric services in the English National Health Service.
- Primary outcome: Quality of Life Scale (QLS) scores, a 45-minute semistructured interview that explores interpersonal relationships (household, friends, social activity), instrumental role (work functioning, work satisfaction), intrapsychic foundations (sense of purpose, motivation, anhedonia).
- Secondary outcomes: Positive and Negative Syndrome Scale (PANSS) score, Calgary depression scale score, Drug Attitudes Inventory, drug adherence scale, Global Assessment of Functioning score, scores on adverse effects (scales for: EPS, akathisia, tardive dyskinesia, others), participant satisfaction.
- Blind assessments at 12, 26, and 56 weeks using intention-to-treat analysis.
- The study’s primary hypothesis was that there would be a clinically meaningful difference in QLS scores between the 2 arms from baseline to 12 months, in favor of SGAs.
- The primary hypothesis that SGAs would offer significantly improved Quality of Life Scale scores during the year, as compared to FGAs, was excluded to the 95% confidence level.
- Costs of the FGA and SGA groups were similar, with inpatient psychiatric care comprising over 80% of costs in both groups. Cost of the antipsychotic drugs comprised less than 4% of total costs in both groups.
- More people in the SGA arm remained in the study than the FGA arm, but the difference was not significant (65% for SGA vs. 54% for FGA, P=0.1). 74% of the 50 patients in the SGA arm who were prescribed olanzapine were still taking the drug at the end of the study.
Jones PB, Barnes TRE, Davies L, Dunn G, Lloyd H, Hayhurst KP, Murray RM, Markwick A, Lewis SW. Randomized controlled trial of the effect on quality of life of second- vs first-generation antipsychotic drugs in schizophrenia. Arch Gen Psychiatry. 2006;63:1079–1087.