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Factors associated with poor satisfaction with treatment and trial discontinuation in chronic schizophrenia

Published online by Cambridge University Press:  05 June 2018

Joep H. Schoemaker Open the ORCID record for Joep H. Schoemaker [Opens in a new window] ,
Ad J.J.M. Vingerhoets  and
Robin A. Emsley
Joep H. Schoemaker*
Affiliation:
Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands
Ad J.J.M. Vingerhoets
Affiliation:
Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands
Robin A. Emsley
Affiliation:
Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, Republic of South Africa
*
*Address for correspondence: Joep Schoemaker, Department of Medical and Clinical Psychology, Tilburg University, P.O. Box 90153, 5000 LE Tilburg, The Netherlands. (Email: j.h.schoemaker@uvt.nl)
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Abstract

Introduction

Despite consistently high discontinuation rates due to withdrawal of consent (WOC) and insufficient therapeutic effect (ITE) in schizophrenia trials, insight into the underlying factors contributing to poor satisfaction with treatment and dropout is limited. A better understanding of these factors could help to improve trial design and completion rates.

Methods

Using data from 1,136 trial participants with schizophrenia or schizoaffective disorder, we explored associations between predictor variables with (1) dropout due to WOC and ITE and (2) satisfaction with treatment among patients and investigators by means of hierarchic multiple regression analyses.

Results

ITE was associated with poor clinical improvement, poor investigator satisfaction with treatment, and poor patient insight into their own disease, whereas WOC only showed a meaningful association with poor patient satisfaction with treatment. Investigator satisfaction with treatment appeared most strongly associated with Positive and Negative Syndrome Scale (PANSS) positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor. The occurrence of severe side effects showed no meaningful association to satisfaction with treatment among investigators and patients, and neither did a patient’s experienced psychopathology, nor their self-rating of functional impairment.

Conclusions

Whereas trial discontinuation due to ITE is associated with poor treatment effectiveness, a patient’s decision to withdraw from an antipsychotic trial remains unpredictable and may occur even when the investigator observes a global clinical improvement and is satisfied with the treatment.

Keywords

Schizophreniadropoutsatisfaction with treatmentpredictorsrandomized controlled trial
Type
Original Research
Information
CNS Spectrums , Volume 24 , Issue 4 , August 2019 , pp. 380 - 389
Copyright
© Cambridge University Press 2018 

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