Generalized Anxiety Disorder
Conditions
Keywords
Generalized Anxiety Disorder
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.
Interventions
DRUGUsual dose treatment of Tandospirone
Usual dose treatment of Tandospirone, oral, 30 mg/day
DRUGComparative high dose of tandospirone treatment
Comparative high dose of tandospirone treatment, oral, 60 mg/day
Sponsors
Sumitomo Pharma (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients whose Hamilton Anxiety Scale (HAMA) score change downwards ≥ 50% from baseline to 6 weeks treatment | 6 weeks | HAMA score changes downwards ≥ 50% indicate significant improvement; HAMA score changes downwards ≥ 75% indicate remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HAMA score changes from baseline to 6 weeks treatment | 6 weeks | 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 | 6 weeks | Scores ≤ 7 indicate non-anxious |
| HAMA factor score changes after treatment | 6 weeks | — |
Countries
China
Outcome results
None listed