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Study Evaluating Long-Term Safety of Effexor XR in Patients With Major Depression.

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ClinicalTrials.gov Identifier: NCT00225524
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

Brief Summary:
Phase III long-term safety study of Effexor XR in patients with major depression.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Long-Term Administration Study of Effexor XR for the Treatment of Depression
Study Start Date : September 2004

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Primary Outcome Measures :
  1. Incidence of adverse events

Secondary Outcome Measures :
  1. Quantitative data for laboratory data


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who complete the Phase III double-blind study (Protocol Number 0600B1-816)

Exclusion Criteria:

  • Patients with schizophrenia or any other psychotic disorder
  • Patients with history or presence of bipolar 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 ClinicalTrials.gov identifier (NCT number): NCT00225524


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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

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ClinicalTrials.gov Identifier: NCT00225524     History of Changes
Other Study ID Numbers: 0600B1-818
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
Venlafaxine Hydrochloride
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