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

November 11, 2011
February 19, 2013
November 2011
January 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01614041 on ClinicalTrials.gov Archive Site
HAMA factor score changes after treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Drug: Usual dose treatment of Tandospirone
    Usual dose treatment of Tandospirone, oral, 30 mg/day
  • Drug: Comparative high dose of tandospirone treatment
    Comparative high dose of tandospirone treatment, oral, 60 mg/day
  • Active Comparator: Control Group
    Usual dose of tandospirone treatment, 30 mg/day
    Intervention: Drug: Usual dose treatment of Tandospirone
  • Experimental: Study Group
    Comparative high dose of tandospirone treatment, 60 mg/day
    Intervention: Drug: Comparative high dose of tandospirone treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
March 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Wenyuan Wu, MD 86-21-66111487 Wuwy@tongji.edu.cn
China
 
NCT01614041
DSPC-SED-1101
Yes
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Not Provided
Principal Investigator: Wenyuan Wu, MD Shanghai Tongji Hospital
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP