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Item Response Theory to Quantify Longitudinal Placebo and Paliperidone Effects on PANSS Scores in Schizophrenia
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.ORCID iD: 0000-0003-0665-6484
Janssen Res & Dev, Beerse, Belgium.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.ORCID iD: 0000-0002-2979-679X
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2017 (English)In: CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, ISSN 2163-8306, Vol. 6, no 8, p. 543-551Article in journal (Refereed) Published
Abstract [en]

As biomarkers are lacking, multi-item questionnaire-based tools like the Positive and Negative Syndrome Scale (PANSS) are used to quantify disease severity in schizophrenia. Analyzing composite PANSS scores as continuous data discards information and violates the numerical nature of the scale. Here a longitudinal analysis based on Item Response Theory is presented using PANSS data from phase III clinical trials. Latent disease severity variables were derived from item-level data on the positive, negative, and general PANSS subscales each. On all subscales, the time course of placebo responses were best described with Weibull models, and dose-independent functions with exponential models to describe the onset of the full effect were used to describe paliperidone's effect. Placebo and drug effect were most pronounced on the positive subscale. The final model successfully describes the time course of treatment effects on the individual PANSS item-levels, on all PANSS subscale levels, and on the total score level.

Place, publisher, year, edition, pages
2017. Vol. 6, no 8, p. 543-551
National Category
Psychiatry Pharmacology and Toxicology
Identifiers
URN: urn:nbn:se:uu:diva-359621DOI: 10.1002/psp4.12207ISI: 000408484200008PubMedID: 28571119OAI: oai:DiVA.org:uu-359621DiVA, id: diva2:1245659
Funder
EU, FP7, Seventh Framework ProgrammeAvailable from: 2018-09-05 Created: 2018-09-05 Last updated: 2018-09-05Bibliographically approved

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Novakovic, Ana M.Friberg, Lena EKarlsson, Mats O.

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