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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Depression

Intervention / Treatment
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* Drug: Trazodone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Depression Rating Scale-17 score | 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. | six weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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losing interest and feelings of guilt, poor concentration, loss of appetite, suicide