Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of comparative high dose Tandospirone Citrate in the treatment of patients with generalized anxiety disorder.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Patient randomized to control group is administrated with usual dose of tandospirone treatment, 30 mg/day |
|
| Study Group | Experimental | Comparative high dose of tandospirone treatment, 60 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual dose treatment of Tandospirone | Drug | Usual dose treatment of Tandospirone, oral, 30 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients whose Hamilton Anxiety Scale (HAMA) score change downwards ≥ 50% from baseline to 6 weeks treatment | HAMA score changes downwards ≥ 50% indicate significant improvement; HAMA score changes downwards ≥ 75% indicate remission | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HAMA score changes from baseline to 6 weeks treatment | Scores 14-21 indicate mild anxiety; scores 21-29 indicate moderate anxiety; scores over 29 indicate severe anxiety | 6 weeks |
| Percentage of patients whose HAMA score ≤ 7 after 6 weeks treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wenyuan Wu, MD | Shanghai Tongji Hospital, Tongji University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tongji Hospital | Shanghai | 200065 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36842964 | Derived | Fu Y, Ji JL, Shi SX, Zhang HY, Lin GZ, Zhang YL, Li X, Wu WY. 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. Curr Med Res Opin. 2023 Apr;39(4):597-603. doi: 10.1080/03007995.2023.2175998. Epub 2023 Feb 26. | |
| 35968511 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparative high dose of tandospirone treatment | Drug | Comparative high dose of tandospirone treatment, oral, 60 mg/day |
|
Scores ≤ 7 indicate non-anxious
| 6 weeks |
| HAMA factor score changes after treatment | 6 weeks |
| 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. Neuropsychiatr Dis Treat. 2022 Aug 8;18:1653-1664. doi: 10.2147/NDT.S366048. eCollection 2022. |