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

Lee's Pharmaceutical

Status and phase: Completed; Phase 3; Phase 2

Conditions: Depression

Treatments: Drug: Trazodone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01524497

Trazodone_1

Details and patient eligibility

About

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.

Enrollment: 382 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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382 participants in 2 patient groups, including a placebo group

Trazodone

Active Comparator group

Treatment:

Drug: Trazodone

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo