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

Sponsor

Lee's Pharmaceutical Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT01524497

Collaborator

(none)

382

Enrollment

Location

Arms

Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Trazodone Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

382 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Trazodone	Drug: Trazodone 75mg tablet/150 mg tablet
Placebo Comparator: Placebo	Drug: Placebo Reference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug)

Arm

Intervention/Treatment

Active Comparator: Trazodone

Drug: Trazodone

75mg tablet/150 mg tablet

Placebo Comparator: Placebo

Drug: Placebo

Reference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug)

Outcome Measures

Primary Outcome Measures

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

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
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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;