In individuals with schizophrenia, implementation of a neuroplasticity-based, computerized cognitive training program has not demonstrated benefits with respect to functional or cognitive capacity outcomes. A 26-week, multisite, randomized, blinded, placebo-controlled, prospective trial — Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults (eCaesar; ClinicalTrials.gov identifier: NCT01422902) — on the topic was conducted and the results were published in the journal Schizophrenia Research.
In the eCaesar study, the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) and the University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA-2) were specified as co-primary outcome measures. Secondary outcome measures included the Cognitive Assessment Interview and the Short-Form-12 Health Survey Mental Component Score (SF-12 MCS). Target engagement was evaluated via utilization of a task learning based assessment.
A total of 150 participants were randomly assigned to the experimental treatment (ET) group or the active control (AC) group. Overall, 7 individuals withdrew from the ET arm and 2 individuals withdrew from the AC arm, yielding an intent-to-treat population of 141 patients (68 in the ET group and 73 in the AC group). The ET arm involved computerized cognitive training in a game like format, whereas the AC arm involved the use of computer games.
The ET and AC groups were well matched at baseline with respect to such demographic characteristics as age, ethnicity, and education level. There were no significant effects reported in the ET arm compared with the AC arm with respect to the primary and secondary outcome measures.
At baseline, the patients who did not complete the final assessment (ie, the drop/withdraw [D/W] population; n=39) were significantly younger than the patients who did complete the final assessment (ie, the fully-evaluable at final assessment time point [FE-V3] population; n=39; P <.01). Moreover, the D/W population had a significantly higher Wide-Range Achievement Test (WRAT) score (P <.01), a significantly higher Positive and Negative Symptoms Scale (PANSS) positive symptom score (P <.01), a significantly higher SF-12 MCS (P <.05), and notably better performance on 2 computerized evaluations of auditory and visual speed (P <.05), compared with the FE-V3 population.
The researchers concluded that the unmet medical need regarding cognitive impairment associated with schizophrenia merits further exploration in order to rigorously assess the use of cognitive training techniques in this population. Future trials should focus on the evaluation of task learning/target engagement, the impact on patient motivation of making the cognitive training game like in design, and the implicit effects of trial requirements on the selection of participants.
Mahncke HW, Kim SJ, Rose A, et al. Evaluation of a plasticity-based cognitive training program in schizophrenia: results from the eCaesar trial [published online March 28, 2019]. Schizophr Res. doi: 10.1016/j.schres.2019.03.006.