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Study Evaluating Effexor XR for Major Depression.

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.
 
ClinicalTrials.gov Identifier: NCT00225511
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : May 24, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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Brief Summary:
Study Evaluating Effexor XR for Major Depression.

Condition or disease Intervention/treatment Phase
Depression Drug: Effexor XR Drug: Milnacipran Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 590 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase III Multi-Center, Double-Blind, Comparative Study of Effexor XR for the Treatment of Depression
Study Start Date : June 2004

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy.

Secondary Outcome Measures :
  1. Difference of total score of HAM-D17 between baseline and final-on-therapy.
  2. Remission rate of HAM-D17 at the final-on-therapy.

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with major depression based on DSM-IV-TR
  • Patients having minimal total score of 18 on the HAM-D17 and minimal score of 2 on the item of "depressed mood" at the baseline.

Exclusion Criteria:

  • Patients with schizophrenia or any other psychotic disorder
  • Patients with history or presence of bipolar disorder
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00225511


Locations
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Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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ClinicalTrials.gov Identifier: NCT00225511    
Other Study ID Numbers: 0600B1-816
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: May 24, 2007
Last Verified: May 2007
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Milnacipran
Venlafaxine Hydrochloride
Levomilnacipran
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents