Early outcomes, associated factors and predictive values of clinical outcomes of tandospirone in generalized anxiety disorder: a post-hoc analysis of a randomized, controlled, multicenter clinical trial

Abstract

Objective

To examine the early outcomes, associated factors and predictive values of clinical outcomes of different tandospirone doses in patients with a generalized anxiety disorder (GAD).

Methods

This was a posthoc analysis of “a randomized, controlled multicenter clinical trial of the efficacy and safety of different doses of tandospirone on GAD”. A total of 274 patients with GAD were included and randomized into the high-dose (tandospirone 60 mg/d) and low-dose (tandospirone 30 mg/d) groups for a 6-week treatment. The Hamilton Anxiety (HAMA), Clinical Global Impression-Severity (CGI-S), Short-Form-12 (SF-12) scales were used for assessment. The trial was registered at clinical trail.gov (NCT01614041).

Results

(1) In the first week of treatment, 35.8% of patients in the high-dose group fulfilled the early onset criteria, which was significantly higher than 19.0% found in the low-dose group (p = 0.002). In the second week of treatment, 22.6% of patients in the high-dose group achieved an early response, versus 12.4% in the low-dose group, indicating a significant difference (p = .026). (2) Factors associated with early onset at week 1 included baseline HAMA total score (OR = 0.916, 95%CI 0.882–0.952), age (OR = 0.974, 95%CI 0.950–0.998), drug dose (30 mg vs. 60 mg; OR = 0.298, 95%CI 0.156–0.568) and SF-12 physiological total score (OR = 1.030, 95%CI 1.010–1.050). (3) Early onset was significantly associated with response rate (OR = 18.34, 95%CI 12.10–27.81), remarkable response rate (OR = 27.56, 95%CI 11.65–65.17) and recovery rate (OR = 11.85, 95%CI 4.98–28.18). Group (high dose group vs. low dose group) (χ² = 8.535, p = .003) and baseline HAMA total score (χ² = 70.840, p < .001) were independent predictors of onset time.

Conclusions

The early outcomes of high-dose tandospirone in the treatment of GAD are better than those of the low-dose group. Patients with younger age at onset, milder anxiety symptoms and better physiological functions administered high-dose tandospirone showed rapid onset, great early outcomes, high recovery rate and good prognosis. Drug onset time had a good predictive effect on treatment outcome.

Keywords:

• Tandospirone
• generalized anxiety disorder
• early outcomes
• clinical outcomes
• associated factors

Transparency

Declaration of financial/other relationships

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Yi Fu and Wen Yuan Wu contributed to the conceptualization and design of the study. Yi Fu, WenYuan Wu, JianLin Ji, Shen Xun Shi, Hai Yin Zhang, Guo Zhen Lin, Ying Li Zhang and Xiuli Li contributed to the study conduct. Yi Fu and Wen Yuan Wu contributed to data analysis and interpretation of results. All authors contributed to revising the article critically for intellectual content. All authors approved the final version to be published and agree to be accountable for all aspects of the work.

Acknowledgements

None.

Ethical statement

This study was approved and supervised by the ethics committee of the Tongji Hospital of Tongji University (Approval No. 117). The written informed consent form was signed by all patients. The trial registration no. was NCT01614041. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Additional information

Funding

This study was supported by the Psychosomatic Medicine Project of Weak Developing Disciplines of Shanghai Municipal Health Commission (2019ZB0202), the Three-Year Initiative Plan for Strengthening Public Health System Construction in Shanghai (GWV-10.2-XD29), and Clinical Research and Training Project of Shanghai Tongji Hospital (ITJ(QN)2009). We wish to thank Sumitomo Pharmaceuticals (Suzhou) Co., Ltd for funding support (No. DSPC-SED-1101). The funders had no role in study design, data collection and analysis, decision to publish, or manuscript preparation.