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

Phase 2

Completed

• Conditions: Depression
• Interventions: Drug: Trazodone; Drug: Placebo

• Registration Number: NCT01524497
• Lead Sponsor: Lee's Pharmaceutical Limited

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 depression in Chinese population.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-02
• Primary Completion: 2013-08
• Study Completion: 2013-11
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trazodone	Trazodone	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Rating Scale-17 score	six weeks	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.

Secondary Outcome Measures

Name	Time	Method
Changes in HAMA-14 score	Six weeks	Change from baseline in HAMA-14 score at Visit 6/final visit
CGI-Severity of illness and CGI-Global improvement	Six weeks	CGI-Severity of illness and CGI-Global improvement at Visit 6/final visit
Rate changes of responders/patients	Six weeks	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.
Changes in evaluation of sleep quality and sexual dysfunction	Six weeks	change from baseline in evaluation of sleep quality and sexual dysfunction at Visit 6/final visit

Trial Locations

Locations (1)

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China