Status:
COMPLETED
A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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 depr...
Eligibility Criteria
Inclusion
- Age between 18 and 65, males and females, outpatients or inpatients;
- Single episode or recurrent depression according to DSM-IV (Version 4) criteria;
- Scores \> 18 on 17-item HAM-D at screening and baseline visits with a decrease not exceeding 20% between the two visits;
- Symptoms of depression for at least 1 month;
- Patients or their dependents/guardians providing signed informed consent forms.
Exclusion
- Serious suicide attempts (≥ 3 on item 3 'Suicide' of HAMD);
- Depressive episode, with psychotic symptoms;
- Refractory depression;
- Depressive episode secondary to other mental or physical disorders;
- Bipolar disorder;
- Significant reduction in body weight and malnutrition induced by major depression;
- Serious or unstable heart, hepatic, renal, endocrine and hematologic disease or malignant tumors;
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT01524497
Start Date
November 1 2011
End Date
November 1 2013
Last Update
October 16 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011