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

January 5, 2020 updated by: Sumitomo Pharma (Suzhou) Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200065
        • Shanghai Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients whose Hamilton Anxiety Scale (HAMA) score change downwards ≥ 50% from baseline to 6 weeks treatment
Time Frame: 6 weeks
HAMA score changes downwards ≥ 50% indicate significant improvement; HAMA score changes downwards ≥ 75% indicate remission
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks
Percentage of patients whose HAMA score ≤ 7 after 6 weeks treatment
Time Frame: 6 weeks
Scores ≤ 7 indicate non-anxious
6 weeks
HAMA factor score changes after treatment
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma (Suzhou) Co., Ltd.

Investigators

  • Principal Investigator: Wenyuan Wu, MD, Shanghai Tongji Hospital, Tongji University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2012

Primary Completion (Actual)

September 11, 2018

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

November 11, 2011

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 5, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSPC-SED-1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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