2023
DOI: 10.4088/jcp.23com14680
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Determining Clinical Follow-Up in the Context of Widening LAI Intervals

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“…An extended earlier review by Berry-Kravis and colleagues 5 on “lessons learned” from some of these trials highlights a range of other issues with trial design and outcome measures as well as limits on the utility of rodent models and translating their results into clinical efficacy designs. The problem of large placebo effects is also raised, 5 and based on the troubling trend of increased placebo responses in schizophrenia over time, 6 the problem is not likely to improve as long as the field depends solely on clinical measures subject to expectation bias. The Berry-Kravis review 5 focuses on most issues that could lead to a signal being missed but not on the possibility that the dose of drug administered might have been inadequate to test engagement of the target in question.…”
mentioning
confidence: 99%
“…An extended earlier review by Berry-Kravis and colleagues 5 on “lessons learned” from some of these trials highlights a range of other issues with trial design and outcome measures as well as limits on the utility of rodent models and translating their results into clinical efficacy designs. The problem of large placebo effects is also raised, 5 and based on the troubling trend of increased placebo responses in schizophrenia over time, 6 the problem is not likely to improve as long as the field depends solely on clinical measures subject to expectation bias. The Berry-Kravis review 5 focuses on most issues that could lead to a signal being missed but not on the possibility that the dose of drug administered might have been inadequate to test engagement of the target in question.…”
mentioning
confidence: 99%