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

NCT01614041 Phase 4 COMPLETED

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.

Details

Lead sponsor	Sumitomo Pharma (Suzhou) Co., Ltd.
Phase	Phase 4
Status	COMPLETED
Enrolment	274
Start date	2012-01-10
Completion	2019-07

Conditions

• Generalized Anxiety Disorder

Interventions

• Usual dose treatment of Tandospirone
• Comparative high dose of tandospirone treatment

Primary outcomes

• 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

Countries

China