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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01977378
• Other study ID #: DVS20130806
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 30, 2013
• Last updated: October 30, 2013
• Start date: October 2013

Study information

• Verified date: October 2013
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Huafang Li, Professor
• Phone: 86-021-34773128
• Email: lhlh_5[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Sustained-Release Desvenlafaxine Hydrochloride

• Sustained-Release Venlafaxine Hydrochloride

Locations

Country	Name	City	State
China	Beijing An Ding Hospital	Beijing
China	Beijing HuiLongGuan Hospital	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital	Chengdu	Sichuan
China	Guangdong General Hospital	Guangzhou	Guangdong
China	The Shanghai Mental Health	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17)		Baseline to Week 10	No
Secondary	Change From Baseline on the Clinical Global Impression Scale		Baseline to Week 10	No
Secondary	Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Scale		Baseline to Week 10	No
Secondary	Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 10		Baseline to Week 10	No
Secondary	Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS)		Baseline to Week 10	No
Secondary	Change From Baseline on the Visual Analogue Scale-Pain Intensity (VAS-PI)		Baseline to Week 10	No
Secondary	Number of Participants in Remission Based on the HAM-D17 at Week 10	Remission was defined as a HAM-D17 score of less than or equal to 7.	Baseline to Week 10	No