Relative Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial

Qingwei Li, Haiyin Zhang, Guozhen Lin, Shenxun Shi, Yingli Zhang, Jianlin Ji, Lipeng Yang, Jun Yao, Wenyuan Wu, Qingwei Li, Haiyin Zhang, Guozhen Lin, Shenxun Shi, Yingli Zhang, Jianlin Ji, Lipeng Yang, Jun Yao, Wenyuan Wu

Abstract

Purpose: To determine the relative safety and efficacy of different doses of tandospirone in treating generalized anxiety disorder (GAD).

Patients and methods: This parallel randomized controlled trial enrolled patients with GAD from eight centers in China. The patients were randomly assigned to 60 mg/day or 30 mg/day tandospirone groups. The primary endpoint was the overall response rate after receiving 6-week treatment. The secondary endpoints included significant response rate, clinical recovery rate, change in the Hamilton Anxiety Scale (HAMA) total score, HAMA subscale score, Hamilton Depression Scale-17 (HAMD-17), Clinical Global Impression-Severity Scale (CGI-S) score, and Impression-Improvement scale (CGI-I) score.

Results: No significant difference was found in the overall response rate between the two groups (65.7% vs 58.4%, p = 0.213). A higher significant response rate and change in the HAMA total score were found in the 60 mg/day group. The reduction in the CGI-S score and percentage of patients with a CGI-I score of ≤2 were higher in 60 mg/day group. The reduction in HAMA somatic anxiety factor, cardiovascular symptom factor, gastrointestinal symptom factor, and HAMD-17 score were more significant in the 60 mg/day group. The incidence of total adverse events was higher in the 60 mg/day group than in the 30 mg/day group. No significant difference was found in the proportion of withdrawal due to adverse events.

Conclusion: Both 60 mg/day and 30 mg/day tandospirone show good efficacy in treating patients with GAD. High doses of tandospirone may have advantages in relieving the somatic symptoms but also present disadvantages due to their high level.

Trial registration: The trial registration no. was NCT01614041.

Keywords: efficacy; generalized anxiety disorder; randomized controlled trial; safety; tandospirone.

Conflict of interest statement

The authors confirm that there are no conflicts of interest.

© 2022 Li et al.

Figures

Figure 1
Figure 1
Flow chart of the study.
Figure 2
Figure 2
Comparison of overall response rate (primary endpoint), significant response rate, recovery rate, CGI-S score≤2 and CGI-I score≤2 between two groups in week 6. Overall response: a decrease in the HAMA total score of ≥ 50% compared to baseline. Significant response: a decrease in the HAMA total score of ≥ 75% relative compared to baseline. Clinical recovery: HAMA score of ≤ 7.
Figure 3
Figure 3
Comparison of the change from baseline of the HAMA total score and HAMA subscale scores between two groups.
Figure 4
Figure 4
Comparison of the change from baseline in the HAMD-17 score between two groups.
Figure 5
Figure 5
Comparison of the change from baseline in the CGI-S score and CGI-I score between two groups.

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