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. 2014 Feb;4(1):4-14.
doi: 10.1177/2045125313499065.

Comparison of the effects of Sertindole and Olanzapine on Cognition (SEROLA): a double-blind randomized 12-week study of patients diagnosed with schizophrenia

René Ernst Nielsen  1 , Florence Odur  2 , Torben Ostergaard  3 , Povl Munk-Jørgensen  4 , Jimmi Nielsen  5
Affiliations

Comparison of the effects of Sertindole and Olanzapine on Cognition (SEROLA): a double-blind randomized 12-week study of patients diagnosed with schizophrenia

René Ernst Nielsen et al. Ther Adv Psychopharmacol. 2014 Feb.

Abstract

Objective: To assess the cognitive effects of sertindole and olanzapine in patients diagnosed with schizophrenia. Cognition was the primary outcome of the study.

Method: This was a 12-week double-blinded randomized clinical controlled trial. Participants were randomized to either 16-24 mg of sertindole or 10-20 mg of olanzapine.

Results: The study had a low recruitment rate (N = 9) and was terminated before the expected number of patients was reached. No significant differences between groups were found at study end on any of the 32 cognitive subtests. A simple sign test did not show any of the comparator drugs trending towards being superior on the majority of tests. Mean change on Positive and Negative Syndrome Scale (PANSS) total and PANSS subscales from baseline to end of study were not significantly different between treatment groups. Similar results on cognition and PANSS was seen on completers and last observation carried forward analysis.

Conclusion: In this study we did not find any significant differences between sertindole or olanzapine on PANSS subscales or neurocognitive tests in a population consisting of patients diagnosed with schizophrenia.

Keywords: cognition; olanzapine; randomized controlled trial; schizophrenia; sertindole.

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Conflict of interest statement

Conflict of interest statement: The Unit for Psychiatric Research provided support with researchers’ salaries and overheads. R. Nielsen has received research grants from H. Lundbeck for clinical trials, received speaking fees from Bristol-Myers Squibb, Astra Zeneca, Janssen & Cilag, Lundbeck, Servier, Otsuka Pharmaceuticals and has acted as advisor to Astra Zeneca and Otsuka Pharmaceuticals. J. Nielsen has received research support from Pfizer and Lundbeck and has received speakers’ honoraria from AstraZeneca, Bristol-Myers Squibb, HemoCue and Lundbeck.

Figures

Figure 1.
Figure 1.
Patient flow throughout the study.
See this image and copyright information in PMC

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