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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01524497
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : October 16, 2014
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Trazodone Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Study on Efficacy And Safety of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression A Multicenter, Randomized, Double-Blind, Parallel Controlled Study
Study Start Date : November 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Trazodone Drug: Trazodone
75mg tablet/150 mg tablet
Placebo Comparator: Placebo Drug: Placebo
Reference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug)

Primary Outcome Measures :
  1. Change in Hamilton Depression Rating Scale-17 score [ Time Frame: 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 Outcome Measures :
  1. Changes in HAMA-14 score [ Time Frame: Six weeks ]
    Change from baseline in HAMA-14 score at Visit 6/final visit

  2. CGI-Severity of illness and CGI-Global improvement [ Time Frame: Six weeks ]
    CGI-Severity of illness and CGI-Global improvement at Visit 6/final visit

  3. Changes in evaluation of sleep quality and sexual dysfunction [ Time Frame: Six weeks ]
    change from baseline in evaluation of sleep quality and sexual dysfunction at Visit 6/final visit

  4. Rate changes of responders/patients [ Time Frame: 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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01524497

China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Study Director: Benjamin LI, Ph.D. Lee's Pharmaceutical company

Responsible Party: Lee's Pharmaceutical Limited Identifier: NCT01524497     History of Changes
Other Study ID Numbers: Trazodone_1
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014

Keywords provided by Lee's Pharmaceutical Limited:
losing interest and feelings of guilt
poor concentration
loss of appetite

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents