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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00452595
First received: March 23, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder
Drug: DVS-233 SR (desvenlafaxine sustained release )
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-Month Open-Label Evaluation of the Long-Term Safety of DVS-233 SR in Outpatients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • HAM-D17

Secondary Outcome Measures:
  • MADRS, CGI-S, CGI-I, Covi Anxiety Scale, SDS, VAS-PI, and WHO-5

Study Start Date: January 2004
Estimated Study Completion Date: May 2005
  Eligibility

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452595

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00452595     History of Changes
Other Study ID Numbers: 3151A1-318
Study First Received: March 23, 2007
Last Updated: March 23, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014