Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder

Phase 4

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Drug: Usual dose treatment of Tandospirone; Drug: Comparative high dose of tandospirone treatment

• Registration Number: NCT01614041
• Lead Sponsor: Sumitomo Pharma (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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-11
• Study Start: 2012-01-10
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-07
• Primary Completion: 2018-09-11
• Study Completion: 2019-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-05
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Usual dose treatment of Tandospirone	Patient randomized to control group is administrated with usual dose of tandospirone treatment, 30 mg/day
Study Group	Comparative high dose of tandospirone treatment	Comparative high dose of tandospirone treatment, 60 mg/day

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
HAMA factor score changes after treatment	6 weeks
HAMA score changes from baseline to 6 weeks treatment	6 weeks	Scores 14-21 indicate mild anxiety; scores 21-29 indicate moderate anxiety; scores over 29 indicate severe anxiety
Percentage of patients whose HAMA score ≤ 7 after 6 weeks treatment	6 weeks	Scores ≤ 7 indicate non-anxious

Trial Locations

Locations (1)

Shanghai Tongji Hospital; 🇨🇳 Shanghai, China