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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trazodone | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trazodone | Drug | 75mg tablet/150 mg tablet |
| |
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin LI, Ph.D. | Lee's Pharmaceutical company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000855 | Anorexia |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D014196 | Trazodone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011728 | Pyridones |
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| Drug |
Reference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug) |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D016728 | Self-Injurious Behavior |
| D011725 |
| Pyridines |