A Double-Blind,Venlafaxine-Controlled Study of Efficacy and Safety of Sustained-Release Desvenlafaxine Hydrochloride in the Treatment of Major Depressive Disorder

Jiangsu Hansoh Pharmaceutical Co., Ltd.6 sites in 1 country300 target enrollmentOctober 2013

ConditionsMajor Depressive Disorder

InterventionsSustained-Release Desvenlafaxine Hydrochloride Sustained-Release Venlafaxine Hydrochloride

DrugsSustained-Release Desvenlafaxine Hydrochloride Sustained-Release Venlafaxine Hydrochloride

Overview

Phase: Phase 2
Intervention: Sustained-Release Desvenlafaxine Hydrochloride
Conditions: Major Depressive Disorder
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Enrollment: 300
Locations: 6
Primary Endpoint: Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17)
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

September 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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

Arms & Interventions

Sustained-Release Desvenlafaxine Hydrochloride

50-100mg/d

Intervention: Sustained-Release Desvenlafaxine Hydrochloride

Sustained-Release Venlafaxine Hydrochloride

75-225mg/d

Intervention: Sustained-Release Venlafaxine Hydrochloride

Outcomes

Primary Outcomes

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

Time Frame: Baseline to Week 10

Secondary Outcomes

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