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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lee's Pharmaceutical Limited
• Treatments: Trazodone

Criteria

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;