Depression | A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression
Depression research study
What is the primary objective of this study?
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 is eligible to participate?
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;
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Trazodone75mg tablet/150 mg tablet
Drug:PlaceboReference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: November 2011
Completed Date: November 2013
Phase: Phase 2/Phase 3
Primary Outcome: Change in Hamilton Depression Rating Scale-17 score
Secondary Outcome: Changes in HAMA-14 score
Study sponsors, principal investigator, and references
Principal Investigator: Benjamin LI, Ph.D.
Lead Sponsor: Lee's Pharmaceutical Limited