This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for treatment of depression in Chinese population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
382
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Change in Hamilton Depression Rating Scale-17 score
17-item Hamilton Depression Rating scale were evaluated at the basemline and six weeks after treatment, the changes were recorded and used as primary outcome measurement.
Time frame: six weeks
Changes in HAMA-14 score
Change from baseline in HAMA-14 score at Visit 6/final visit
Time frame: Six weeks
CGI-Severity of illness and CGI-Global improvement
CGI-Severity of illness and CGI-Global improvement at Visit 6/final visit
Time frame: Six weeks
Changes in evaluation of sleep quality and sexual dysfunction
change from baseline in evaluation of sleep quality and sexual dysfunction at Visit 6/final visit
Time frame: Six weeks
Rate changes of responders/patients
rate of responders, defined as patients with a 50% improvement from baseline in the HAMD score at Visit6/final visit;or rate of patients with remission, defined as patients with HAMD score ≤7 at Visit 6/final visit.
Time frame: Six weeks
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