Relative Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial
Qingwei Li,1 Haiyin Zhang,2 Guozhen Lin,3 Shenxun Shi,4 Yingli Zhang,5 Jianlin Ji,6 Lipeng Yang,7 Jun Yao,1 Wenyuan Wu1 1Department of Psychiatry, Tongji Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China; 2Clinical Psychology, Shanghai Mental Health Center, Shangha...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2022-08-01
|
| Series: | Neuropsychiatric Disease and Treatment |
| Subjects: | |
| Online Access: | https://www.dovepress.com/relative-safety-and-efficacy-of-two-doses-of-tandospirone-citrate-for--peer-reviewed-fulltext-article-NDT |
| _version_ | 1811322505884860416 |
|---|---|
| author | Li Q Zhang H Lin G Shi S Zhang Y Ji J Yang L Yao J Wu W |
| author_facet | Li Q Zhang H Lin G Shi S Zhang Y Ji J Yang L Yao J Wu W |
| author_sort | Li Q |
| collection | DOAJ |
| description | Qingwei Li,1 Haiyin Zhang,2 Guozhen Lin,3 Shenxun Shi,4 Yingli Zhang,5 Jianlin Ji,6 Lipeng Yang,7 Jun Yao,1 Wenyuan Wu1 1Department of Psychiatry, Tongji Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China; 2Clinical Psychology, Shanghai Mental Health Center, Shanghai, People’s Republic of China; 3Department of Psychiatry, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China; 4Psychiatry Department, Fudan University Affiliated Huashan Hospital, Shanghai, People’s Republic of China; 5Department of Depressive Disorders, Shenzhen Kangning Hospital, Shenzhen Mental Health Center, Shenzhen, People’s Republic of China; 6Department of Psychological Medicine, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China; 7Department of Neurology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, People’s Republic of ChinaCorrespondence: Wenyuan Wu, Department of Psychiatry, Tongji Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China, Email wuwy@tongji.edu.cnPurpose: 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: generalized anxiety disorder, tandospirone, randomized controlled trial, safety, efficacy |
| first_indexed | 2024-04-13T13:36:07Z |
| format | Article |
| id | doaj.art-b41fc37d433c4d90b6f88c97fbce66f4 |
| institution | Directory Open Access Journal |
| issn | 1178-2021 |
| language | English |
| last_indexed | 2024-04-13T13:36:07Z |
| publishDate | 2022-08-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Neuropsychiatric Disease and Treatment |
| spelling | doaj.art-b41fc37d433c4d90b6f88c97fbce66f42022-12-22T02:44:47ZengDove Medical PressNeuropsychiatric Disease and Treatment1178-20212022-08-01Volume 181653166477201Relative Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled TrialLi QZhang HLin GShi SZhang YJi JYang LYao JWu WQingwei Li,1 Haiyin Zhang,2 Guozhen Lin,3 Shenxun Shi,4 Yingli Zhang,5 Jianlin Ji,6 Lipeng Yang,7 Jun Yao,1 Wenyuan Wu1 1Department of Psychiatry, Tongji Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China; 2Clinical Psychology, Shanghai Mental Health Center, Shanghai, People’s Republic of China; 3Department of Psychiatry, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China; 4Psychiatry Department, Fudan University Affiliated Huashan Hospital, Shanghai, People’s Republic of China; 5Department of Depressive Disorders, Shenzhen Kangning Hospital, Shenzhen Mental Health Center, Shenzhen, People’s Republic of China; 6Department of Psychological Medicine, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China; 7Department of Neurology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, People’s Republic of ChinaCorrespondence: Wenyuan Wu, Department of Psychiatry, Tongji Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China, Email wuwy@tongji.edu.cnPurpose: 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: generalized anxiety disorder, tandospirone, randomized controlled trial, safety, efficacyhttps://www.dovepress.com/relative-safety-and-efficacy-of-two-doses-of-tandospirone-citrate-for--peer-reviewed-fulltext-article-NDTgeneralized anxiety disordertandospironerandomized controlled trialsafetyefficacy |
| spellingShingle | Li Q Zhang H Lin G Shi S Zhang Y Ji J Yang L Yao J Wu W Relative Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial Neuropsychiatric Disease and Treatment generalized anxiety disorder tandospirone randomized controlled trial safety efficacy |
| title | Relative Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial |
| title_full | Relative Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial |
| title_fullStr | Relative Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial |
| title_full_unstemmed | Relative Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial |
| title_short | Relative Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial |
| title_sort | relative safety and efficacy of two doses of tandospirone citrate for generalized anxiety disorder a multicenter randomized controlled trial |
| topic | generalized anxiety disorder tandospirone randomized controlled trial safety efficacy |
| url | https://www.dovepress.com/relative-safety-and-efficacy-of-two-doses-of-tandospirone-citrate-for--peer-reviewed-fulltext-article-NDT |
| work_keys_str_mv | AT liq relativesafetyandefficacyoftwodosesoftandospironecitrateforgeneralizedanxietydisorderamulticenterrandomizedcontrolledtrial AT zhangh relativesafetyandefficacyoftwodosesoftandospironecitrateforgeneralizedanxietydisorderamulticenterrandomizedcontrolledtrial AT ling relativesafetyandefficacyoftwodosesoftandospironecitrateforgeneralizedanxietydisorderamulticenterrandomizedcontrolledtrial AT shis relativesafetyandefficacyoftwodosesoftandospironecitrateforgeneralizedanxietydisorderamulticenterrandomizedcontrolledtrial AT zhangy relativesafetyandefficacyoftwodosesoftandospironecitrateforgeneralizedanxietydisorderamulticenterrandomizedcontrolledtrial AT jij relativesafetyandefficacyoftwodosesoftandospironecitrateforgeneralizedanxietydisorderamulticenterrandomizedcontrolledtrial AT yangl relativesafetyandefficacyoftwodosesoftandospironecitrateforgeneralizedanxietydisorderamulticenterrandomizedcontrolledtrial AT yaoj relativesafetyandefficacyoftwodosesoftandospironecitrateforgeneralizedanxietydisorderamulticenterrandomizedcontrolledtrial AT wuw relativesafetyandefficacyoftwodosesoftandospironecitrateforgeneralizedanxietydisorderamulticenterrandomizedcontrolledtrial |