Clinical Trial Details

NCT ID: NCT01614041
Date Last Changed: May 19, 2015

Overview

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

Purpose

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.

To Learn more

Recruitment Details

Phase
4
Gender
Both Male and Female
Age
18 to 65 Years
Overall Status
Recruiting
Lead Sponsor
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Duration
45 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female 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

Contact

Wenyuan Wu, MD
86-21-66111487
E-mail:

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