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

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ClinicalTrials.gov Identifier: NCT01614041
Recruitment Status : Recruiting
First Posted : June 7, 2012
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Generalized Anxiety Disorder Drug: Usual dose treatment of Tandospirone Drug: Comparative high dose of tandospirone treatment Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. HAMA factor score changes after treatment [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Tongji University School of Medicine

Responsible Party: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT01614041     History of Changes
Other Study ID Numbers: DSPC-SED-1101
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016

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

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Citric Acid
Tandospirone
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents