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Trial record 1 of 1 for:    NCT01309542
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Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01309542
Recruitment Status : Completed
First Posted : March 7, 2011
Last Update Posted : April 26, 2011
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Brief Summary:
The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR) during open-label treatment in adult outpatients who had a primary diagnosis of major depressive disorder (MDD). The study also evaluated the long-term response of subjects receiving DVS SR for clinical global evaluation, functionality, general well-being, pain, and absence of depressive symptoms (remission).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Desvenlafaxine Succinate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1403 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 10 Month Open-Label Evaluation Of The Long-Term Safety Of DVS-233 SR In Outpatients With Major Depressive Disorder.
Study Start Date : August 2003
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DVS Drug: Desvenlafaxine Succinate
Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months
Other Name: DVS-233 SR

Primary Outcome Measures :
  1. Number (%) of Subjects Reporting Adverse Events during Treatment [ Time Frame: 10 months ]
  2. Number (%) of Subjects With Changes in Vital Signs (Blood Pressure, Pulse Rate, Weight) of Potential Clinical Importance [ Time Frame: 10 months ]
  3. Number (%) of Subjects With Laboratory Test Results (Hematology, Blood Chemistry, Lipid Profile, Urinalysis) of Potential Clinical Importance [ Time Frame: 10 months ]
  4. Number (%) of Subjects With Electrocardiogram Results (Heart Rate, QTc interval) of Potential Clinical Importance [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. Change in Hamilton Depression Rating scale - 17 items version - (HAM-D17) mean score from baseline [ Time Frame: 10 months ]
  2. Change in Montgomery Asberg Depression Rating Scale (MADRS)mean score from baseline [ Time Frame: 10 months ]
  3. Change in Clinical Global Improvement Scale-Severity (CGI-S)mean score from baseline [ Time Frame: 10 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Outpatients who have completed double-blind therapy in a phase 3 DVS-233 SR short-term study for the indication of MDD, including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.
  • Sexually active individuals participating in the study must use a medically acceptable form of contraception during the trial and for at least 15 days after the last dose of study drug.

Exclusion Criteria:

  • Clinically important abnormalities on baseline physical examination, or any unresolved clinically significant abnormalities on ECG, laboratory test results, or vital signs recorded in a previous phase 3 DVS-233 SR short-term study for the indication of MDD. Any exception must be discussed with and granted by the sponsor.
  • 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.
  • Presence of clinically important hepatic or renal disease or other medical disease that might compromise the study or be detrimental to the subject (eg, clinically important cardiac arrhythmia, uncontrolled diabetes, uncontrolled hypertension, seizure disorder, myocardial infarction, neurologic disorder, acute illness, neoplastic disorder).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01309542

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01309542    
Other Study ID Numbers: 3151A1-303
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: April 2011
Keywords provided by Pfizer:
major depressive disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs