Comparison of quetiapine and risperidone in Chinese Han patients with schizophrenia: results of a single-blind, randomized study

Abstract

Objective:

To evaluate the efficacy and safety of 750 mg/day quetiapine fumarate (Seroquel) in the treatment of Chinese Han patients with schizophrenia.

Methods:

In this 6-week, multicenter, randomized, rater single-blind study, a total of 119 patients with schizophrenia were randomly assigned to quetiapine (n = 60, 750 mg/day) or risperidone (n = 59, 4 mg/day). The efficacy was assessed by the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression–Change (CGI-C) and the Calgary Depression Scale for Schizophrenia (CDSS). Safety and tolerability assessments included treatment-emergent adverse events, laboratory tests and electrocardiograms.

Results:

The primary analysis demonstrated no significant difference between treatment in the two groups (quetiapine vs. risperidone: 31.9 ± 17.5 vs. 33.3 ± 17.3; P = 0.668). Improvements with both treatments were comparable for total PANSS, positive and negative subscores, general psychopathology subscales, and excitement and attack symptoms. Improvements in CGI-S were similar between treatment groups (P = 0.046). A more favorable trend was detected for quetiapine than risperidone in the reduction of CDSS scores from baseline, especially at week 1 (1.1 ± 2.2 vs. 0.3 ± 2.1, P < 0.050).

The rate of extrapyramidal symptom (EPS) and hyperprolactinemia-related adverse events was significantly lower in the quetiapine group than the risperidone group (13.3% vs. 43.3%, P < 0.001). Dizziness and somnolence were more common in the quetiapine group than the risperidone group.

Conclusion:

Quetiapine fumarate (750 mg/day) has broad clinical efficacy comparable to 4 mg/day risperidone. Dizziness was common in the quetiapine group (P = 0.029), but the rate of somnolence was similar between the two groups (P = 0.114). EPS and hyperprolactinemia rates were significantly higher with risperidone (P < 0.001). Key limitations of this study include small sample size, short treatment periods, and no increase to 6 mg/day for risperidone because of its safety profile.

Keywords::

• Efficacy
• Quetiapine fumarate
• Randomized controlled study
• Safety
• Schizophrenia

Transparency

Declaration of funding

This study was sponsored by AstraZeneca Pharmaceuticals.

Declaration of financial/other interests

Y.Li and H.L. contributed equally as co-first authors on this paper. H.L., Y.Liu, Y.Y. and M.Q. have disclosed that they have all worked as consultants for AstraZeneca Pharmaceuticals.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors would like to acknowledge the assistance of Yuefen Tang of AstraZeneca, who provided medical input during manuscript development.

The study group is as follows: Niufan Gu, Huafang Li, Yan Li, and Yan Liu, Shanghai Mental Health Center, Shanghai; Yin Yue, Luwan Mental Health Center, Shanghai; Mincai Qian, Huzhou Third People’s Hospital, Huzhou; Yuefen Tang, Qiang Xu and Jie Yang, AstraZeneca Pharmaceuticals, Shanghai, China.

Notes

*Seroquel is a registered trade name of AstraZeneca Pharmaceuticals, Shanghai, China.

†Seroquel is a registered trade name of AstraZeneca Pharmaceuticals, Shanghai, China.