Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

— TACGAD  

Official title:

Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder: a Multi-center, Randomized, Usual Dose-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614041
• Other study ID #: DSPC-SED-1101
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2012
• Est. completion date: July 2019

Study information

• Verified date: January 2020
• Source: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: July 2019
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder

Intervention

Drug:
• Usual dose treatment of Tandospirone
Usual dose treatment of Tandospirone, oral, 30 mg/day
• Comparative high dose of tandospirone treatment
Comparative high dose of tandospirone treatment, oral, 60 mg/day

Locations

Country	Name	City	State
China	Shanghai Tongji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients whose Hamilton Anxiety Scale (HAMA) score change downwards = 50% from baseline to 6 weeks treatment	HAMA score changes downwards = 50% indicate significant improvement; HAMA score changes downwards = 75% indicate remission	6 weeks
Secondary	HAMA score changes from baseline to 6 weeks treatment	Scores 14-21 indicate mild anxiety; scores 21-29 indicate moderate anxiety; scores over 29 indicate severe anxiety	6 weeks
Secondary	Percentage of patients whose HAMA score = 7 after 6 weeks treatment	Scores = 7 indicate non-anxious	6 weeks
Secondary	HAMA factor score changes after treatment		6 weeks