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Study Evaluating Effexor XR in Elderly Patients With Major Depression.

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ClinicalTrials.gov Identifier: NCT00225485
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : May 28, 2007
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
Phase III study evaluating Effexor XR in elderly patients with major depression.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase III Study of Effexor XR for the Treatment of Elderly Patients With Depression
Study Start Date : December 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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" of HAM-D at baseline

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): NCT00225485

Ichikawa, Chiba, Japan, 272-0034
Ichikawa, Chiba, Japan, 272-0827
Kasuga, Fukuoka, Japan, 816-0801
Kitakyushu, Fukuoka, Japan, 802-8533
Ohnojo, Fukuoka, Japan, 816-0943
Otaru, Hokkaido, Japan, 047-0032
Sapporo, Hokkaido, Japan, 003-0804
Sapporo, Hokkaido, Japan, 005-0004
Sapporo, Hokkaido, Japan, 005-0842
Sapporo, Hokkaido, Japan, 006-8555
Sapporo, Hokkaido, Japan, 011-0022
Sapporo, Hokkaido, Japan, 060-0007
Sapporo, Hokkaido, Japan, 063-0804
Sapporo, Hokkaido, Japan, 064-0915
Sapporo, Hokkaido, Japan, 065-0027
Tsukuba, Ibaragi, Japan, 305-8576
Hanamaki, Iwate, Japan, 025-0033
Kawasaki, Kanagawa, Japan, 211-0063
Kawasaki, Kanagawa, Japan, 213-8507
Sagamihara, Kanagawa, Japan, 228-0803
Yokohama, Kanagawa, Japan, 224-8503
Yokohama, Kanagawa, Japan, 227-8501
Moriguchi, Osaka, Japan, 570-8506
Osakasayama, Osaka, Japan, 589-0011
Osakasayama, Osaka, Japan, 589-8511
Sakai, Osaka, Japan, 590-0018
Adachi-ku, Tokyo, Japan, 120-0033
Chiyoda-ku, Tokyo, Japan, 101-8643
Fuchu, Tokyo, Japan, 183-8524
Higashimurayama, Tokyo, Japan, 189-0012
Kodaira, Tokyo, Japan, 187-8551
Meguro-ku, Tokyo, Japan, 152-0012
Nakano-ku, Tokyo, Japan, 164-0003
Setagaya-ku, Tokyo, Japan, 154-0004
Tachikawa, Tokyo, Japan, 190-0012
Hiroshima, Japan, 731-0121
Okayama, Japan, 700-8558
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier: NCT00225485     History of Changes
Other Study ID Numbers: 0600B1-817
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: May 28, 2007
Last Verified: May 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Additional relevant MeSH terms:
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