A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Clinical Study on Efficacy And Safety of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression A Multicenter, Randomized, Double-Blind, Parallel Controlled Study|
- Change in Hamilton Depression Rating Scale-17 score [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]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.
- Changes in HAMA-14 score [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]Change from baseline in HAMA-14 score at Visit 6/final visit
- CGI-Severity of illness and CGI-Global improvement [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]CGI-Severity of illness and CGI-Global improvement at Visit 6/final visit
- Changes in evaluation of sleep quality and sexual dysfunction [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]change from baseline in evaluation of sleep quality and sexual dysfunction at Visit 6/final visit
- Rate changes of responders/patients [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||November 2011|
|Study Completion Date:||November 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Trazodone||
75mg tablet/150 mg tablet
|Placebo Comparator: Placebo||
Reference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524497
|The Second Xiangya Hospital of Central South University|
|Changsha, Hunan, China, 410011|
|Study Director:||Benjamin LI, Ph.D.||Lee's Pharmaceutical company|