A Study of Sustained-Release Desvenlafaxine Hydrochloride for the Treatment of Major Depressive Disorder
NCT ID: NCT01977378
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sustained-Release Desvenlafaxine Hydrochloride
50-100mg/d
Sustained-Release Desvenlafaxine Hydrochloride
Sustained-Release Venlafaxine Hydrochloride
75-225mg/d
Sustained-Release Venlafaxine Hydrochloride
Interventions
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Sustained-Release Desvenlafaxine Hydrochloride
Sustained-Release Venlafaxine Hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Jiangsu Hansoh Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Huafang Li, Professor
Role: PRINCIPAL_INVESTIGATOR
The Shanghai Mental Health
Locations
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Guangdong General Hospital
Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
West China Hospital
Chengdu, Sichuan, China
Beijing An Ding Hospital
Beijing, , China
Beijing HuiLongGuan Hospital
Beijing, , China
The Shanghai Mental Health
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Huafang Li, Professor
Role: primary
Other Identifiers
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DVS20130806
Identifier Type: -
Identifier Source: org_study_id