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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Sumitomo Pharmaceutical (Suzhou) Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01614041
First received: November 11, 2011
Last updated: February 19, 2013
Last verified: June 2012
  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.


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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01614041

Contacts
Contact: Wenyuan Wu, MD 86-21-66111487 Wuwy@tongji.edu.cn

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

No publications provided

Responsible Party: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT01614041     History of Changes
Other Study ID Numbers: DSPC-SED-1101
Study First Received: November 11, 2011
Last Updated: February 19, 2013
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes
Tandospirone
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Receptor Agonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014