A novel way to quantify schizophrenia symptoms in clinical trials

Medvedev, ON, Berk, M, Dean, OM, Brown, E, Sandham, MH, Dipnall, JF, McNamara, RK, Sumich, A ORCID: https://orcid.org/0000-0003-4333-8442, Krägeloh, CU, Narayanan, A and Siegert, RJ, 2021. A novel way to quantify schizophrenia symptoms in clinical trials. European Journal of Clinical Investigation, 51 (3): e13398. ISSN 0014-2972

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Abstract

Background: A major problem in quantifying symptoms of schizophrenia is establishing a reliable distinction between enduring and dynamic aspects of psychopathology. This is critical for accurate diagnosis, monitoring and evaluating treatment effects in both clinical practice and trials.

Materials and methods: We applied Generalizability Theory, a robust novel method to distinguish between dynamic and stable aspects of schizophrenia symptoms in the widely used Positive and Negative Symptom Scale (PANSS) using a longitudinal measurement design. The sample included 107 patients with chronic schizophrenia assessed using the PANSS at five time points over a 24‐week period during a multi‐site clinical trial of N‐Acetylcysteine as an add‐on to maintenance medication for the treatment of chronic schizophrenia.

Results: The original PANSS and its three subscales demonstrated good reliability and generalizability of scores (G = 0.77‐0.93) across sample population and occasions making them suitable for assessment of psychosis risks and long‐lasting change following a treatment, while subscales of the five‐factor models appeared less reliable. The most enduring symptoms represented by the PANSS were poor attention, delusions, blunted affect and poor rapport. More dynamic symptoms with 40%‐50% of variance explained by patient transient state including grandiosity, preoccupation, somatic concerns, guilt feeling and hallucinatory behaviour.

Conclusions: Identified dynamic symptoms are more amendable to change and should be the primary target of interventions aiming at effectively treating schizophrenia. Separating out the dynamic symptoms would increase assay sensitivity in trials, reduce the signal to noise ratio and increase the potential to detect the effects of novel therapies in clinical trials.

Item Type:	Journal article
Publication Title:	European Journal of Clinical Investigation
Creators:	Medvedev, O.N., Berk, M., Dean, O.M., Brown, E., Sandham, M.H., Dipnall, J.F., McNamara, R.K., Sumich, A., Krägeloh, C.U., Narayanan, A. and Siegert, R.J.
Publisher:	Wiley
Date:	March 2021
Volume:	51
Number:	3
ISSN:	0014-2972
Identifiers:	Number Type 10.1111/eci.13398 DOI 1408783 Other
Rights:	© 2020 The Authors. European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Divisions:	Schools > School of Social Sciences
Record created by:	Jonathan Gallacher
Date Added:	19 Feb 2021 10:10
Last Modified:	31 May 2021 15:05
URI:	https://irep.ntu.ac.uk/id/eprint/42328

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