A Study of Sustained-Release Desvenlafaxine Hydrochloride for the Treatment of Major Depressive Disorder

October 30, 2013 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.

A Double-Blind,Venlafaxine-Controlled Study of Efficacy and Safety of Sustained-Release Desvenlafaxine Hydrochloride in the Treatment of Major Depressive Disorder

A multicenter, 10-week study to evaluate the efficacy and safety of Sustained-Release Desvenlafaxine Hydrochloride versus Sustained-Release venlafaxine Hydrochloride in adult with major depressive disorder.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100096
        • Recruiting
        • Beijing HuiLongGuan Hospital
      • Beijing, China, 100088
        • Recruiting
        • Beijing An Ding hospital
      • Shanghai, China, 200030
        • Recruiting
        • The Shanghai Mental Health
        • Contact:
          • Huafang Li, Professor
          • Phone Number: 86-021-34773128
          • Email: lhlh_5@163.com
        • Principal Investigator:
          • Huafang Li, Professor
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong General Hospital
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • The Second Xiangya Hospital Of Central South University
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult with primary diagnosis of Major Depressive Disorder
  • Aged from 18 years to 65 years
  • A primary diagnosis of Major Depressive Disorder based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features
  • Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of ≧ 20
  • Clinical Global Impressions Scale-Severity (CGI-S) score of ≧4

Exclusion Criteria:

  • Known hypersensitivity to desvenlafaxine or venlafaxine
  • Significant risk of suicide based on clinical judgment
  • Women who were pregnant,breast-feeding,or planning to become pregnant during study
  • Had a history of seizure disorder
  • History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs
  • Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
  • Cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sustained-Release Desvenlafaxine Hydrochloride
50-100mg/d
Drug: Sustained-Release Desvenlafaxine Hydrochloride
Active Comparator: Sustained-Release Venlafaxine Hydrochloride
75-225mg/d
Drug: Sustained-Release Venlafaxine Hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17)
Time Frame: Baseline to Week 10
Baseline to Week 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline on the Clinical Global Impression Scale
Time Frame: Baseline to Week 10
Baseline to Week 10
Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Scale
Time Frame: Baseline to Week 10
Baseline to Week 10
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 10
Time Frame: Baseline to Week 10
Baseline to Week 10
Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline to Week 10
Baseline to Week 10
Change From Baseline on the Visual Analogue Scale-Pain Intensity (VAS-PI)
Time Frame: Baseline to Week 10
Baseline to Week 10
Number of Participants in Remission Based on the HAM-D17 at Week 10
Time Frame: Baseline to Week 10
Remission was defined as a HAM-D17 score of less than or equal to 7.
Baseline to Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Huafang Li, Professor, The Shanghai Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

October 30, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DVS20130806

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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