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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524497
• Other study ID #: Trazodone_1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 13, 2012
• Last updated: October 14, 2014
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: October 2014
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: November 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	six weeks	Yes
Secondary	Changes in HAMA-14 score	Change from baseline in HAMA-14 score at Visit 6/final visit	Six weeks	Yes
Secondary	CGI-Severity of illness and CGI-Global improvement	CGI-Severity of illness and CGI-Global improvement at Visit 6/final visit	Six weeks	Yes
Secondary	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	Six weeks	Yes
Secondary	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.	Six weeks	Yes