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Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder (TACGAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Information provided by (Responsible Party):
Sumitomo Pharmaceutical (Suzhou) Co., Ltd. Identifier:
First received: November 11, 2011
Last updated: October 13, 2016
Last verified: October 2016
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.

Condition Intervention Phase
Generalized Anxiety Disorder
Drug: Usual dose treatment of Tandospirone
Drug: Comparative high dose of tandospirone treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder: a Multi-center, Randomized, Usual Dose-controlled Trial

Resource links provided by NLM:

Further study details as provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:

Primary Outcome Measures:
  • Hamilton Anxiety Scale (HAMA) score changes from baseline to 6 weeks treatment [ Time Frame: 6 weeks ]
    Scores 14-21 indicate mild anxiety; scores 21-29 indicate moderate anxiety; scores over 29 indicate severe anxiety

Secondary Outcome Measures:
  • HAMA factor score changes after treatment [ Time Frame: 6 weeks ]

Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group
Patient randomized to control group is administrated with usual dose of tandospirone treatment, 30 mg/day
Drug: Usual dose treatment of Tandospirone
Usual dose treatment of Tandospirone, oral, 30 mg/day
Experimental: Study Group
Comparative high dose of tandospirone treatment, 60 mg/day
Drug: Comparative high dose of tandospirone treatment
Comparative high dose of tandospirone treatment, oral, 60 mg/day


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01614041

Contact: Wenyuan Wu, MD 86-21-66111487

Shanghai Tongji Hospital Recruiting
Shanghai, China, 200065
Contact: Wenyuan Wu, MD         
Sponsors and Collaborators
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Principal Investigator: Wenyuan Wu, MD Shanghai Tongji Hospital, Tongji University School of Medicine
  More Information

Responsible Party: Sumitomo Pharmaceutical (Suzhou) Co., Ltd. Identifier: NCT01614041     History of Changes
Other Study ID Numbers: DSPC-SED-1101
Study First Received: November 11, 2011
Last Updated: October 13, 2016

Keywords provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Pathologic Processes
Mental Disorders
Citric Acid
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Chelating Agents
Chelating Agents
Sequestering Agents processed this record on May 25, 2017