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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.
- Source :
- Current Medical Research & Opinion; Apr2023, Vol. 39 Issue 4, p597-603, 7p
- Publication Year :
- 2023
-
Abstract
- 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). 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). (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) (χ<superscript>2</superscript> = 8.535, p =.003) and baseline HAMA total score (χ<superscript>2</superscript> = 70.840, p <.001) were independent predictors of onset time. 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. [ABSTRACT FROM AUTHOR]
- Subjects :
- GENERALIZED anxiety disorder
TREATMENT effectiveness
CLINICAL trials
AGE of onset
Subjects
Details
- Language :
- English
- ISSN :
- 03007995
- Volume :
- 39
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- Current Medical Research & Opinion
- Publication Type :
- Academic Journal
- Accession number :
- 163111100
- Full Text :
- https://doi.org/10.1080/03007995.2023.2175998