Clinical Trial Details

NCT ID: NCT01614041
Date Last Changed: October 13, 2016


Research Study Summary

A Phase 4 clinical study for patients with Generalized Anxiety Disorder

Research Study Title

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


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.

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Recruitment Details

18 to 65 Years
Overall Status
Lead Sponsor
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
61 Months
Facility Type


All ages 18 Years to 65 Years

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

Site Locations (1)

Country State City Zip Facility and Contact
China Shanghai 200065 Shanghai Tongji Hospital
Wenyuan Wu, MD


Wenyuan Wu, MD

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