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Status unknownNCT01977378Updated Nov 6, 2013

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

A Phase 2/3 interventional study of Sustained-Release Desvenlafaxine Hydrochloride and Sustained-Release Venlafaxine Hydrochloride in Major Depressive Disorder, sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. Status unknown at 6 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-06.

Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depressive Disorder
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's planned enrollment of 300 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. is the lead sponsor of 131 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
300 participants (estimated)

Study arms

  • 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

Interventions

  • DrugSustained-Release Desvenlafaxine Hydrochloride
  • DrugSustained-Release Venlafaxine Hydrochloride
06

What researchers measure

Primary outcomes

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

    Time frame: Baseline to Week 10

Secondary outcomes

  1. Change From Baseline on the Clinical Global Impression Scale

    Time frame: Baseline to Week 10

  2. Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Scale

    Time frame: Baseline to Week 10

  3. Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 10

    Time frame: Baseline to Week 10

  4. Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: Baseline to Week 10

  5. Change From Baseline on the Visual Analogue Scale-Pain Intensity (VAS-PI)

    Time frame: Baseline to Week 10

  6. 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.

    Time frame: Baseline to Week 10

07

Study locations

6 of 6 sites recruiting
  • Guangdong General Hospital
    Guangzhou, Guangdong, China
    Recruiting
  • The Second Xiangya Hospital of Central South University
    Changsha, Hunan, China
    Recruiting
  • West China Hospital
    Chengdu, Sichuan, China
    Recruiting
  • Beijing An Ding Hospital
    Beijing, 100088, China
    Recruiting
  • Beijing HuiLongGuan Hospital
    Beijing, 100096, China
    Recruiting
  • The Shanghai Mental Health
    Shanghai, 200030, China
    • Huafang Li, Professor · Contact · lhlh_5@163.com · 86-021-34773128
    • Huafang Li, Professor · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01977378
Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Nov 6, 2013
Start date
Oct 2013
Primary completion
Sep 2014 (estimated)
Last update
Nov 6, 2013

Study contacts

Huafang Li, Professor
Contact
lhlh_5@163.com
86-021-34773128
Huafang Li, Professor
principal investigator · The Shanghai Mental Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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