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A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression

Information source: Lee's Pharmaceutical Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: Trazodone (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Lee's Pharmaceutical Limited

Official(s) and/or principal investigator(s):
Benjamin LI, Ph.D., Study Director, Affiliation: Lee's Pharmaceutical company


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Hamilton Depression Rating Scale-17 score

Secondary outcome:

Changes in HAMA-14 score

CGI-Severity of illness and CGI-Global improvement

Changes in evaluation of sleep quality and sexual dysfunction

Rate changes of responders/patients


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria: 1. Age between 18 and 65, males and females, outpatients or inpatients; 2. Single episode or recurrent depression according to DSM-IV (Version 4) criteria; 3. Scores > 18 on 17-item HAM-D at screening and baseline visits with a decrease not exceeding 20% between the two visits; 4. Symptoms of depression for at least 1 month; 5. Patients or their dependents/guardians providing signed informed consent forms. Exclusion Criteria: 1. Serious suicide attempts (≥ 3 on item 3 'Suicide' of HAMD); 2. Depressive episode, with psychotic symptoms; 3. Refractory depression; 4. Depressive episode secondary to other mental or physical disorders; 5. Bipolar disorder; 6. Significant reduction in body weight and malnutrition induced by major depression; 7. Serious or unstable heart, hepatic, renal, endocrine and hematologic disease or malignant tumors;

Locations and Contacts

The Second Xiangya Hospital of Central South University, Changsha, Hunan 410011, China
Additional Information

Starting date: November 2011
Last updated: October 14, 2014

Page last updated: August 23, 2015

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