The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) recommended that drugs that exert a pro-cognitive effect should be accompanied by measurable improvements in a functionally-meaningful endpoint.
Several instruments have been developed that seek to capture the subjective experience and impact of cognitive dysfunction on daily living in patients with schizophrenia for use as co-primary endpoints in clinical trials.
However, it remains unclear to what extent these accurately reflect objective cognitive performance or whether they are influenced by other aspects of illness.
For this research, presented at SIRS 2018, we conducted a secondary analysis of data from 413 patients with schizophrenia who participated in multi-national, randomised, double-blind, placebo-controlled trial.
During the trial, participants completed two different neurocognitive test batteries, the Cambridge Neuropsychological Test Automated Battery (CANTAB) and the MATRICS Consensus Cognitive Battery (MCCB).
Scores on each of the subjective measures of cognition were weakly correlated in the expected direction with objective measures of cognitive performance across both the CANTAB and MCCB tasks, but were more strongly associated with symptom severity as assessed using the PANSS.
The research indicated that subjective appraisals of cognition are poor predictors of objective cognitive performance in patients with schizophrenia.
Interested in learning more about the drivers of subjective cognitive complaints in patients with schizophrenia? Download this poster.