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

NCT01524497 | Completed Phase 2 DMC

• 1 other identifier: Trazodone_1
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

losing interest and feelings of guilt; poor concentration; loss of appetite; suicide

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Changes in HAMA-14 score

  Six weeks

• CGI-Severity of illness and CGI-Global improvement

  Six weeks

• Changes in evaluation of sleep quality and sexual dysfunction

  Six weeks

• Rate changes of responders/patients

  Six weeks

Study Arms (2)

Trazodone

ACTIVE COMPARATOR

Drug: Trazodone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Trazodone DRUG

75mg tablet/150 mg tablet

Trazodone

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Depression; Anorexia; Suicide

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Officials

• Benjamin LI, Ph.D.

  Lee's Pharmaceutical company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: February 2, 2012
• Study Start: November 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 16, 2014

Record last verified: 2014-10

Locations

CN (1)