Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00798707

Purpose

The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR) Drug: placebo	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Succinic acid Desvenlafaxine Succinate Desvenlafaxine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (25 and 50 mg/Day) of DVS SR Tablets in Adult Outpatients With Major Depressive Disorder

Further study details as provided by Wyeth:

Primary Outcome Measures:

Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) [ Time Frame: Approximately 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary efficacy outcome measures include the CGI-I and S, MADRS and HAM-D 6. Secondary safety outcome measures include AE, suicidality and discontinuation symptom monitoring, physical and vital signs, ECGs, and changes in sexual functioning. [ Time Frame: Approximately 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	678
Study Start Date:	December 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
DVS SR 25 mg: Experimental	Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
DVS SR 50 mg: Experimental	Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Placebo: Placebo Comparator	Drug: placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening)
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:

Clinical instability - 25% or greater increase/decrease in HAM-D 17 total score from screening to baseline
Significant risk of suicide as assessed by clinician judgement, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798707

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Japan, Kanagawa
	Recruiting
Yokohama, Kanagawa, Japan, 2210835
Japan, Tokyo
	Recruiting
Setagaya, Tokyo, Japan, 1540012

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3151A1-3359
Study First Received:	November 25, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00798707
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency; United States: Food and Drug Administration

Keywords provided by Wyeth:

Major Depressive Disorder

Study placed in the following topic categories:

Depression
O-desmethylvenlafaxine
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009