Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder (TACGAD)
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Usual dose treatment of Tandospirone
Comparative high dose of tandospirone treatment
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder
Eligibility Criteria
Inclusion Criteria:
- 18-65 years old
- 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:
- Serious suicidal tendency
- 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
Sites / Locations
- Shanghai Tongji Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Study Group
Arm Description
Patient randomized to control group is administrated with usual dose of tandospirone treatment, 30 mg/day
Comparative high dose of tandospirone treatment, 60 mg/day
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Percentage of patients whose HAMA score ≤ 7 after 6 weeks treatment
Scores ≤ 7 indicate non-anxious
HAMA factor score changes after treatment
Full Information
NCT ID
NCT01614041
First Posted
November 11, 2011
Last Updated
January 5, 2020
Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01614041
Brief Title
Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder
Acronym
TACGAD
Official Title
Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder: a Multi-center, Randomized, Usual Dose-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2012 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patient randomized to control group is administrated with usual dose of tandospirone treatment, 30 mg/day
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Comparative high dose of tandospirone treatment, 60 mg/day
Intervention Type
Drug
Intervention Name(s)
Usual dose treatment of Tandospirone
Intervention Description
Usual dose treatment of Tandospirone, oral, 30 mg/day
Intervention Type
Drug
Intervention Name(s)
Comparative high dose of tandospirone treatment
Intervention Description
Comparative high dose of tandospirone treatment, oral, 60 mg/day
Primary Outcome Measure Information:
Title
Percentage of patients whose Hamilton Anxiety Scale (HAMA) score change downwards ≥ 50% from baseline to 6 weeks treatment
Description
HAMA score changes downwards ≥ 50% indicate significant improvement; HAMA score changes downwards ≥ 75% indicate remission
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
HAMA score changes from baseline to 6 weeks treatment
Description
Scores 14-21 indicate mild anxiety; scores 21-29 indicate moderate anxiety; scores over 29 indicate severe anxiety
Time Frame
6 weeks
Title
Percentage of patients whose HAMA score ≤ 7 after 6 weeks treatment
Description
Scores ≤ 7 indicate non-anxious
Time Frame
6 weeks
Title
HAMA factor score changes after treatment
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-65 years old
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:
Serious suicidal tendency
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenyuan Wu, MD
Organizational Affiliation
Shanghai Tongji Hospital, Tongji University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tongji Hospital
City
Shanghai
ZIP/Postal Code
200065
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35968511
Citation
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.
Results Reference
derived
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Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder
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