The Use of Cognitive Screening in Pharmacotherapy Trials for Cognitive Impairment Associated With Schizophrenia
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 f...
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doaj-a65ea29b483a489db768a4ea5782d3632020-11-25T01:12:22ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402019-09-011010.3389/fpsyt.2019.00648475137The Use of Cognitive Screening in Pharmacotherapy Trials for Cognitive Impairment Associated With SchizophreniaJack Cotter0Jennifer H. Barnett1Jennifer H. Barnett2Kiri Granger3Cambridge Cognition, Cambridge, United KingdomCambridge Cognition, Cambridge, United KingdomDepartment of Psychiatry, University of Cambridge, Cambridge, United KingdomCambridge Cognition, Cambridge, United KingdomThere 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 randomized, double-blind, placebo-controlled, add-on pharmacotherapy trials conducted in patients with a diagnosis of schizophrenia, in which a paper-and-pencil or computerized 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.https://www.frontiersin.org/article/10.3389/fpsyt.2019.00648/fullclinical trialcognitionpharmacotherapypsychosisschizophreniatrial methodology |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Jack Cotter Jennifer H. Barnett Jennifer H. Barnett Kiri Granger |
spellingShingle |
Jack Cotter Jennifer H. Barnett Jennifer H. Barnett Kiri Granger The Use of Cognitive Screening in Pharmacotherapy Trials for Cognitive Impairment Associated With Schizophrenia Frontiers in Psychiatry clinical trial cognition pharmacotherapy psychosis schizophrenia trial methodology |
author_facet |
Jack Cotter Jennifer H. Barnett Jennifer H. Barnett Kiri Granger |
author_sort |
Jack Cotter |
title |
The Use of Cognitive Screening in Pharmacotherapy Trials for Cognitive Impairment Associated With Schizophrenia |
title_short |
The Use of Cognitive Screening in Pharmacotherapy Trials for Cognitive Impairment Associated With Schizophrenia |
title_full |
The Use of Cognitive Screening in Pharmacotherapy Trials for Cognitive Impairment Associated With Schizophrenia |
title_fullStr |
The Use of Cognitive Screening in Pharmacotherapy Trials for Cognitive Impairment Associated With Schizophrenia |
title_full_unstemmed |
The Use of Cognitive Screening in Pharmacotherapy Trials for Cognitive Impairment Associated With Schizophrenia |
title_sort |
use of cognitive screening in pharmacotherapy trials for cognitive impairment associated with schizophrenia |
publisher |
Frontiers Media S.A. |
series |
Frontiers in Psychiatry |
issn |
1664-0640 |
publishDate |
2019-09-01 |
description |
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 randomized, double-blind, placebo-controlled, add-on pharmacotherapy trials conducted in patients with a diagnosis of schizophrenia, in which a paper-and-pencil or computerized 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. |
topic |
clinical trial cognition pharmacotherapy psychosis schizophrenia trial methodology |
url |
https://www.frontiersin.org/article/10.3389/fpsyt.2019.00648/full |
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