Personalized Treatment With Second vs. First Generation Antipsychotics
The primary outcome in this study was the change in total quality-of-life scores from baseline to week 24 after patients were randomly assigned to a treatment group.
New research findings published in Lancet Psychiatry indicate that patients diagnosed with schizophrenia who are treated with second-generation antipsychotics (SGAs) report significant improvement of quality of life, overall wellbeing, and social performance when compared with patients who were prescribed first-generation antipsychotics (FGAs).
In this double-blind, randomized study, investigators recruited participants (aged 18-65 years) who were diagnosed with schizophrenia (ICD-10 F20.X) from 14 psychiatric university hospitals in Germany. Physicians across different hospitals first assessed individual needs of each of the patients (total across all 14 centers was 149 patients), and then assigned them to a group that received one of the FGAs [flupentixol (n=42); haloperidol (n=27)], or to a group that received one of the SGAs [aripiprazole (n=23); olanzapine (n=25); quetiapine (n=32)].
“Randomly assigned patients with a patient-oriented decision who received the drug that was selected by the physician remained in the study for longer than patients who received a drug selected only at random [median time in the trial 58 days (IQR 34-96) vs. 25.5 days (20-57); P=0.2250],” investigators wrote in their publication.
The primary outcome in this study was the change in total quality-of-life scores from baseline to week 24 after patients were randomly assigned to a treatment group. Investigators assessed the change by using the sum of the physical and mental component summary of the Short Form 36 Health Survey (SF-36), and by using the Clinical Global Impression-Improvement (CGI-I) scale.
Secondary outcomes were assessed by analyzing the change between baseline and week 24 in total score by using the Subjective Well-Being Under Neuroleptic Treatment Scale, short form (SWN-K). Researchers also analyzed the change in total score by using the Personal and Social Performance Scale (PSP), as well as the change in total score and subscores on the Positive and Negative Syndrome Scale (PANSS).
Patients who were assigned to each of the treatment groups did not differ significantly in terms of age, sex, ethnicity, illness duration, or baseline scores of the primary outcome. Treatment selection behavior of physicians did not differ between the groups, and the hospital where patients were recruited did not affect the primary outcome to a significant degree. More than 75% of patients did terminate their treatment prematurely.
In terms of the primary outcome, “improvement of quality of life was statistically and clinically significantly higher in patients given SGA antipsychotics than in patients given FGAs,” the authors wrote.
With regard to secondary endpoints, data indicate that patients treated with SGAs scored significantly higher on various subscales of the SF-36. More specifically, SGAs were shown to be significantly superior to FGAs with regard to the following subscores of the SF-36: vitality, emotional role functioning, physical role functioning, and physical component summary.
“Although the result certainly needs confirmation in a larger patient cohort…. newer compounds could indeed provide some benefit in terms of subjective wellbeing for a substantial number of patients,” investigators concluded.
Gründer G, Heinze M, Cordes J, et al. Effects of first-generation antipsychotics versus second-generation antipsychotics on quality of life in schizophrenia: a double-blind, randomised study. Lancet Psychiatry. 2016;3(8):717-729.