Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder

Marubeni Pharmaceuticals (Suzhou) Co., Ltd.274 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

274

Conditions

Generalized Anxiety Disorder

Interventions

Usual dose treatment of TandospironeDRUG

Usual dose treatment of Tandospirone, oral, 30 mg/day

Comparative high dose of tandospirone treatmentDRUG

Comparative high dose of tandospirone treatment, oral, 60 mg/day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Tongji Hospital

Shanghai, China

Outcomes

Primary Outcomes

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

Time frame: 6 weeks

Secondary Outcomes

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

Time frame: 6 weeks

Percentage of patients whose HAMA score ≤ 7 after 6 weeks treatment

Scores ≤ 7 indicate non-anxious

Time frame: 6 weeks

HAMA factor score changes after treatment

Time frame: 6 weeks

Data from ClinicalTrials.gov

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