Study Evaluating Desvenlafaxine Succinate Sustained Release in Outpatients With Major Depressive Disorder

This study is currently recruiting participants.

Verified by Wyeth, May 2009

First Received: January 14, 2009 Last Updated: May 6, 2009 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00824291

Purpose

This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.

Condition	Intervention	Phase
Depressive Disorder, Major	Drug: desvenlafaxine succinate sustained release Genetic: Genotyping	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Desvenlafaxine Succinic acid Desvenlafaxine Succinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study To EVvaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release

Further study details as provided by Wyeth:

Primary Outcome Measures:

Change in HAM-D17 score from baseline after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare DVS SR to placebo on Sheehan Disability Scale,Clinical Global Impression,MontgomeryAsberg Depression Rating Scale,Quality of Life Enjoyment & Satisfaction Questionnaire,Work Productivity & Activity Impairment,Arizona Sexual Experiences Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	February 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: desvenlafaxine succinate sustained release
2: Experimental	Genetic: Genotyping

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Outpatient men and women, 18 to 75 years, fluent in both written and spoken English.
Employed for 20 hours or more for a minimum of 1 month prior to baseline.
Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.

Exclusion:

Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
Treatment-resistant in the past 3 years to ≥2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824291

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Show 53 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3151A1-4415
Study First Received:	January 14, 2009
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00824291 History of Changes
Health Authority:	Canada: Ethics Review Committee; Canada: Health Canada; United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
O-desmethylvenlafaxine
Mental Disorders
Psychotropic Drugs

Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder

Pharmacologic Actions
Behavioral Symptoms
Pathologic Processes
Mental Disorders
O-desmethylvenlafaxine
Therapeutic Uses
Mood Disorders
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009