Psychiatria Fennica (Oct 2023)
REPRESENTATIVENESS OF CLINICAL ANTIPSYCHOTIC TRIAL SAMPLES WHEN COMPARED WITH A GENERAL POPULATION-BASED SAMPLE
Abstract
Background: Antipsychotics are effective in controlled environments for treatment of schizophrenia. However, there is hardly any research on the effects of antipsychotics in years-long follow-ups in antipsychotic trials. In addition, study samples of the antipsychotic trials differ quite notably from the day-to-day clinical treatment population. In this study, we aimed to compare the population-based Northern Finland Birth Cohort 1966 (NFBC1966) population to the samples in antipsychotic trials using typical inclusion and exclusion criteria found in randomized clinical trials (RCTs). We also compared long-term outcomes of individuals with schizophrenia meeting and not meeting inclusion criteria for clinical trials. Method: We gathered clinical antipsychotic trials and their inclusion and exclusion criteria. These inclusion and exclusion criteria were compared to the data of NFBC1966 to find out how many of the 54 participants in NFBC1966 34-year follow-up would meet these criteria, and how representative outcomes of the clinical antipsychotic trials are compared to a longitudinal population-based sample. Result: Depending on how strict the inclusion and exclusion criteria of the RCTs were, 10.5 to 24.6 per cent of the participants in the NFBC1966 34-year follow-up could have been included in RCTs using the criteria. Notably, 42.1 per cent of the participants in the NFBC1966 would be excluded without considering PANSS as inclusion criteria. There was no statistically significant difference in the distribution of PANSS and SOFAS scores between the included and excluded groups in longitudinal analysis. However, in the distribution of hospital treatment days in the groups included and excluded by criteria of RCTs, there was a statistically significant difference between the groups. Conclusions: Over one-third of the participants of this population sample could have been excluded from clinical trials without even considering psychotic symptoms as an inclusion criterion.
