Study Evaluating DVS-233 for Treatment of Outpatients With Major Depressive Disorder

A 12-Month Open-Label Evaluation of the Long-Term Safety of DVS-233 SR in Outpatients With Major Depressive Disorder

To evaluate the long-term safety of desvenlafaxine sustained release (DVS-233SR) during open-label treatment of outpatients with major depressive disorder (MDD).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: DVS-233 SR (desvenlafaxine sustained release )

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Outpatients.
• Men and women aged 18 to 75 years.
• Women of childbearing potential must have a negative serum pregnancy test result at screening. Sexually active individuals participating in this study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article.
• Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features, on study day 1. If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present. (See Exclusion Criterion 6 for psychiatric diagnoses that are not allowable.)
• Depressive symptoms for at least 30 days before the screening visit.
• Subjects who have symptoms of depression judged by the investigator to require long-term treatment (i.e., 6 months or longer) with an antidepressant drug.

Other inclusion applies.

Exclusion Criteria:

• Treatment with DVS-233 SR at any time in the past.
• Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1.
• Known hypersensitivity to venlafaxine (IR or ER).
• Significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
• Current (within 12 months of baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder as assessed by the modified Mini International Neuropsychiatric Interview (MINI). Current (within 12 months of baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder as assessed by the modified MINI and considered by the investigator to be primary, causing a higher degree of distress or impairment than MDD. Presence (within 12 months of baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic).
• Depression associated with the presence of an organic mental disorder due to a general medical condition or a neurologic disorder.
• History of a seizure disorder other than a single childhood febrile seizure.

Other exclusion applies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HAM-D17

Secondary Outcome Measures

Outcome Measure
MADRS, CGI-S, CGI-I, Covi Anxiety Scale, SDS, VAS-PI, and WHO-5

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Study Completion: May 1, 2005

Study Registration Dates

• First Submitted: March 23, 2007
• First Submitted That Met QC Criteria: March 23, 2007
• First Posted (Estimate): March 27, 2007

Study Record Updates

• Last Update Posted (Estimate): March 27, 2007
• Last Update Submitted That Met QC Criteria: March 23, 2007
• Last Verified: March 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Desvenlafaxine Succinate
• Other Study ID Numbers: 3151A1-318