CompletedPhase 2/3

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

China382 participantsStarted 2011-11

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

What they're measuring

Change in Hamilton Depression Rating Scale-17 score

Timeframe: six weeks

Trial details

NCT IDNCT01524497

SponsorLee's Pharmaceutical Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-08

View on ClinicalTrials.gov More Depression trials