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

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Trazodone
Placebo
Sponsored by
Lee's Pharmaceutical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring losing interest and feelings of guilt, poor concentration, loss of appetite, suicide

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • The Second Xiangya Hospital of Central South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Trazodone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Hamilton Depression Rating Scale-17 score
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

Changes in HAMA-14 score
Change from baseline in HAMA-14 score at Visit 6/final visit
CGI-Severity of illness and CGI-Global improvement
CGI-Severity of illness and CGI-Global improvement at Visit 6/final visit
Changes in evaluation of sleep quality and sexual dysfunction
change from baseline in evaluation of sleep quality and sexual dysfunction at Visit 6/final visit
Rate changes of responders/patients
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.

Full Information

First Posted
January 13, 2012
Last Updated
October 14, 2014
Sponsor
Lee's Pharmaceutical Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01524497
Brief Title
A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
losing interest and feelings of guilt, poor concentration, loss of appetite, suicide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
382 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trazodone
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Trazodone
Intervention Description
75mg tablet/150 mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Reference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug)
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Rating Scale-17 score
Description
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.
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Changes in HAMA-14 score
Description
Change from baseline in HAMA-14 score at Visit 6/final visit
Time Frame
Six weeks
Title
CGI-Severity of illness and CGI-Global improvement
Description
CGI-Severity of illness and CGI-Global improvement at Visit 6/final visit
Time Frame
Six weeks
Title
Changes in evaluation of sleep quality and sexual dysfunction
Description
change from baseline in evaluation of sleep quality and sexual dysfunction at Visit 6/final visit
Time Frame
Six weeks
Title
Rate changes of responders/patients
Description
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.
Time Frame
Six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin LI, Ph.D.
Organizational Affiliation
Lee's Pharmaceutical company
Official's Role
Study Director
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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