Depression
Conditions
Keywords
losing interest and feelings of guilt, poor concentration, loss of appetite, suicide
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.
Interventions
DRUGTrazodone
75mg tablet/150 mg tablet
DRUGPlacebo
Reference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug)
Sponsors
Lee's Pharmaceutical Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed