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Trial record 23 of 89 for:    DESVENLAFAXINE

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

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ClinicalTrials.gov Identifier: NCT01977378
Recruitment Status : Unknown
Verified October 2013 by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : November 6, 2013
Last Update Posted : November 6, 2013
Sponsor:
Information provided by (Responsible Party):
Jiangsu Hansoh Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Sustained-Release Desvenlafaxine Hydrochloride Drug: Sustained-Release Venlafaxine Hydrochloride Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2013
Estimated Primary Completion Date : September 2014


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



Primary Outcome Measures :
  1. Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) [ Time Frame: Baseline to Week 10 ]

Secondary Outcome Measures :
  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 [ Time Frame: Baseline to Week 10 ]
    Remission was defined as a HAM-D17 score of less than or equal to 7.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977378


Contacts
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Contact: Huafang Li, Professor 86-021-34773128 lhlh_5@163.com

Locations
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China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China
China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China
China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China
China
Beijing An Ding Hospital Recruiting
Beijing, China, 100088
Beijing HuiLongGuan Hospital Recruiting
Beijing, China, 100096
The Shanghai Mental Health Recruiting
Shanghai, China, 200030
Contact: Huafang Li, Professor    86-021-34773128    lhlh_5@163.com   
Principal Investigator: Huafang Li, Professor         
Sponsors and Collaborators
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Huafang Li, Professor The Shanghai Mental Health

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Responsible Party: Jiangsu Hansoh Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01977378     History of Changes
Other Study ID Numbers: DVS20130806
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Desvenlafaxine Succinate
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs