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

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sustained-Release Desvenlafaxine Hydrochloride
Sustained-Release Venlafaxine Hydrochloride
Sponsored by
Jiangsu Hansoh Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

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

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

Sites / Locations

  • Guangdong General HospitalRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • West China HospitalRecruiting
  • Beijing An Ding HospitalRecruiting
  • Beijing HuiLongGuan HospitalRecruiting
  • The Shanghai Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sustained-Release Desvenlafaxine Hydrochloride

Sustained-Release Venlafaxine Hydrochloride

Arm Description

50-100mg/d

75-225mg/d

Outcomes

Primary Outcome Measures

Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17)

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2013
Last Updated
October 30, 2013
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01977378
Brief Title
A Study of Sustained-Release Desvenlafaxine Hydrochloride for the Treatment of Major Depressive Disorder
Official Title
A Double-Blind,Venlafaxine-Controlled Study of Efficacy and Safety of Sustained-Release Desvenlafaxine Hydrochloride in the Treatment of Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sustained-Release Desvenlafaxine Hydrochloride
Arm Type
Experimental
Arm Description
50-100mg/d
Arm Title
Sustained-Release Venlafaxine Hydrochloride
Arm Type
Active Comparator
Arm Description
75-225mg/d
Intervention Type
Drug
Intervention Name(s)
Sustained-Release Desvenlafaxine Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Sustained-Release Venlafaxine Hydrochloride
Primary Outcome Measure Information:
Title
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17)
Time Frame
Baseline to Week 10
Secondary Outcome Measure Information:
Title
Change From Baseline on the Clinical Global Impression Scale
Time Frame
Baseline to Week 10
Title
Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Scale
Time Frame
Baseline to Week 10
Title
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 10
Time Frame
Baseline to Week 10
Title
Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame
Baseline to Week 10
Title
Change From Baseline on the Visual Analogue Scale-Pain Intensity (VAS-PI)
Time Frame
Baseline to Week 10
Title
Number of Participants in Remission Based on the HAM-D17 at Week 10
Description
Remission was defined as a HAM-D17 score of less than or equal to 7.
Time Frame
Baseline to Week 10

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huafang Li, Professor
Phone
86-021-34773128
Email
lhlh_5@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huafang Li, Professor
Organizational Affiliation
The Shanghai Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing An Ding Hospital
City
Beijing
ZIP/Postal Code
100088
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing HuiLongGuan Hospital
City
Beijing
ZIP/Postal Code
100096
Country
China
Individual Site Status
Recruiting
Facility Name
The Shanghai Mental Health
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huafang Li, Professor
Phone
86-021-34773128
Email
lhlh_5@163.com
First Name & Middle Initial & Last Name & Degree
Huafang Li, Professor

12. IPD Sharing Statement

Learn more about this trial

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

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