Clinical trial NCT01977378: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17)
timeFrame: Baseline to Week 10
Secondary outcomes:
measure: Change From Baseline on the Clinical Global Impression Scale
timeFrame: Baseline to Week 10
measure: Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Scale
timeFrame: Baseline to Week 10
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 10
timeFrame: Baseline to Week 10
measure: Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline to Week 10
measure: Change From Baseline on the Visual Analogue Scale-Pain Intensity (VAS-PI)
timeFrame: Baseline to Week 10
measure: Number of Participants in Remission Based on the HAM-D17 at Week 10
timeFrame: Baseline to Week 10
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Beijing
country: China
facility: Beijing An Ding Hospital
city: Beijing
country: China
facility: Beijing HuiLongGuan Hospital
city: Shanghai
country: China
facility: The Shanghai Mental Health
Study officials:
affiliation: The Shanghai Mental Health
name: Huafang Li, Professor
role: PRINCIPAL_INVESTIGATOR
References: