Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Treatments: Citric Acid; Tandospirone

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