Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder: a Multi-center, Randomized, Usual Dose-controlled Trial

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Drug: Usual dose treatment of Tandospirone
* Drug: Comparative high dose of tandospirone treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Patient randomized to control group is administrated with usual dose of tandospirone treatment, 30 mg/day | Drug: Usual dose treatment of Tandospirone<br>* Usual dose treatment of Tandospirone, oral, 30 mg/day<br>|
| Experimental: Study Group<br>Comparative high dose of tandospirone treatment, 60 mg/day | Drug: Comparative high dose of tandospirone treatment<br>* Comparative high dose of tandospirone treatment, oral, 60 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Scores ≤ 7 indicate non-anxious | 6 weeks | 
| HAMA factor score changes after treatment |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Anxiety Disorder