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

Phase 2

• Conditions: Major Depressive Disorder
• Interventions: Drug: Sustained-Release Desvenlafaxine Hydrochloride; Drug: Sustained-Release Venlafaxine Hydrochloride

• Registration Number: NCT01977378
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-10
• Study Start: 2013-10
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Last Update Submitted: 2013-10-30
• Study First Posted: 2013-11-06
• Last Update Posted: 2013-11-06
• Primary Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sustained-Release Desvenlafaxine Hydrochloride	Sustained-Release Desvenlafaxine Hydrochloride	50-100mg/d
Sustained-Release Venlafaxine Hydrochloride	Sustained-Release Venlafaxine Hydrochloride	75-225mg/d

Primary Outcome Measures

Name	Time	Method
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17)	Baseline to Week 10

Secondary Outcome Measures

Name	Time	Method
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	Remission was defined as a HAM-D17 score of less than or equal to 7.
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

Trial Locations

Locations (6)

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

West China Hospital; 🇨🇳 Chengdu, Sichuan, China

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

Beijing An Ding Hospital; 🇨🇳 Beijing, China

The Shanghai Mental Health; 🇨🇳 Shanghai, China

Beijing HuiLongGuan Hospital; 🇨🇳 Beijing, China