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

Sumitomo Pharma

Status and phase

Completed

Phase 4

Conditions

Generalized Anxiety Disorder

Treatments

Drug: Usual dose treatment of Tandospirone

Drug: Comparative high dose of tandospirone treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01614041

DSPC-SED-1101

Details and patient eligibility

About

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.

Enrollment

274 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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