Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder
NCT ID: NCT01614041
Last Updated: 2020-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
274 participants
INTERVENTIONAL
2012-01-10
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
Patient randomized to control group is administrated with usual dose of tandospirone treatment, 30 mg/day
Usual dose treatment of Tandospirone
Usual dose treatment of Tandospirone, oral, 30 mg/day
Study Group
Comparative high dose of tandospirone treatment, 60 mg/day
Comparative high dose of tandospirone treatment
Comparative high dose of tandospirone treatment, oral, 60 mg/day
Interventions
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Usual dose treatment of Tandospirone
Usual dose treatment of Tandospirone, oral, 30 mg/day
Comparative high dose of tandospirone treatment
Comparative high dose of tandospirone treatment, oral, 60 mg/day
Eligibility Criteria
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Inclusion Criteria
* Male or female
* Diagnosed with GAD according to DSM-IV
* HAMA score≥17
* Provide with written informed consent
* Agree to be washed-out for two weeks if receiving SSRI, SNRI or NASA.
Exclusion Criteria
* The score of the sixth item of HAMA ≥3
* The score of HAMD ≥21
* Pregnant or lactating women
* History of allergic or hypersensitivity to tandospirone
* Serious or unstable cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease
* Secondary anxiety disorders
* Drug or alcohol dependence within 1 year
* Patients currently taking benzodiazepine drugs
* Drivers and dangerous machine operators
* Participated in other clinical studies in the last 30 days
* Patients with clinically significant ECG or laboratory abnormalities
* Patients with a history of epilepsy
* Patients with abnormal TSH concentration
18 Years
65 Years
ALL
No
Sponsors
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Sumitomo Pharma (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wenyuan Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Tongji Hospital, Tongji University School of Medicine
Locations
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Shanghai Tongji Hospital
Shanghai, , China
Countries
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References
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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.
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.
Other Identifiers
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DSPC-SED-1101
Identifier Type: -
Identifier Source: org_study_id
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