Mini Review ARTICLE
The use of cognitive screening in pharmacotherapy trials for cognitive impairment associated with schizophrenia
- 1Cambridge Cognition (United Kingdom), United Kingdom
There are currently no regulatory approved pharmacological treatments for cognitive impairment associated with schizophrenia (CIAS). One possibility is that trial methodology itself is hindering their development. Emerging evidence suggests that patients with schizophrenia may show limited benefit from pro-cognitive interventions if they already exhibit intact cognitive performance, relative to normative thresholds. The aim of this report was to examine the extent to which objectively assessed cognitive performance has been used as an eligibility and/or stratification criterion in CIAS pharmacotherapy trials. On 16th January 2019, we conducted a systematic search of studies listed on ClinicalTrials.gov to identify randomised, double-blind, placebo-controlled, add-on pharmacotherapy trials conducted in patients with a diagnosis of schizophrenia, in which a paper-and-pencil or computerised cognitive task (or battery) was specified as a primary outcome measure. Of the 87 trials that met our inclusion criteria, 10 (11.5%) required the presence of an objectively assessed cognitive deficit as part of their patient eligibility criteria. No studies reported stratifying patients according to the presence or degree of cognitive impairment they exhibited. These results suggest that the vast majority of CIAS trials may have been underpowered due to the inclusion of cognitively ‘normal’ patients. Purposive screening for cognitive impairment could increase CIAS trial success.
Keywords: Clinical Trial, Cognition, Pharmacotherapy, psychosis, Schizophrenia, Trial methodology
Received: 06 Jun 2019;
Accepted: 12 Aug 2019.
Copyright: © 2019 Cotter, Barnett and Granger. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Dr. Jack Cotter, Cambridge Cognition (United Kingdom), Cambridge, United Kingdom, email@example.com