Paliperidone Compared with Haloperidol on the Theory of Mind Tasks in Schizophrenia: A Pilot Trial

Jie Zhong; Hong Zhu; Dongqing Yin; Yanzhe Ning; Sisi Zheng; Yanbo Zhang; Hongxiao Jia

doi:10.2147/NDT.S335597

Paliperidone Compared with Haloperidol on the Theory of Mind Tasks in Schizophrenia: A Pilot Trial

Neuropsychiatr Dis Treat. 2021 Dec 14:17:3683-3691. doi: 10.2147/NDT.S335597. eCollection 2021.

Authors

Jie Zhong^#^{1

2}, Hong Zhu^#^{1

2}, Dongqing Yin^{1

2}, Yanzhe Ning^{1

2}, Sisi Zheng^{1

2}, Yanbo Zhang³, Hongxiao Jia^{1

2}

Affiliations

¹ The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, People's Republic of China.
² Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, People's Republic of China.
³ Department of Psychiatry, Faculty of Medicine, and Dentistry, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada.

^# Contributed equally.

Abstract

Purpose: Theory of mind (ToM) is an important part of social cognitive function and is associated with medial prefrontal cortical (mPFC) activity. This study aimed to evaluate the efficacy of paliperidone in improving ToM task performance in patients with schizophrenia compared with haloperidol.

Patients and methods: This study was a single-center, single-blinded (assessor), parallel-group randomized clinical trial of patients with schizophrenia randomized to paliperidone or haloperidol. ToM was assessed at weeks 0, 8, 12, and 16 using the first-order belief, higher-order belief, faux-pas, and Reading the Mind in the Eyes tests. The primary outcome was the change in the ToM performance scores from baseline to after 16 weeks of treatment.

Results: The participants received paliperidone (n = 29) or haloperidol (n = 31). For the first-order belief task, there were no between-group differences (P > 0.05) but time differences in both groups (P < 0.05). For the higher-order belief task, there were no between-group differences (P > 0.05), but there were time differences in both groups (P < 0.05) and a time×group interaction in the paliperidone group only (P < 0.05). For the faux-pas task, there was a difference between groups at week 16 (P < 0.05), and the improvement in time was significant for the paliperidone group only (P < 0.05). For the Reading the Mind in the Eyes task, there was an improvement over time for the paliperidone group only (P < 0.05). Safety was manageable in both groups.

Conclusion: Paliperidone treatment might be more effective than haloperidol in improving ToM task performance in schizophrenia.

Trial registration: chictr.org.cn_identifier ChiCTR-IPR-15007635.

Keywords: haloperidol; longitudinal study; paliperidone; schizophrenia; theory of mind.

Grants and funding

This study was funded using an investigator-initiated grant from Xi’an Janssen Pharmaceutical Company. This funder had no role in study design, collection, analysis, and interpretation of the data, in the report’s writing, and in the decision to submit the paper for publication. This study was also partially supported by Beijing Hospital Authority Youth Programme (code:QML20191001), Beijing Natural Science Foundation (Grant no.7212050), Beijing Hospitals Authority Clinical Medicine Development of Special Funding Support (Grant no.ZYLX202129) Beijing Hospitals Authority's Ascent Plan (Grant no.DFL20191901), Capital’s Funds for Health Improvement and Research (Grant no.2018-1-2122, 2020-4-2126).