Study Evaluating Effexor XR in Elderly Patients With Major Depression.

May 25, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Phase III Study of Effexor XR for the Treatment of Elderly Patients With Depression

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hiroshima, Japan, 731-0121
      • Okayama, Japan, 700-8558
    • Chiba
      • Ichikawa, Chiba, Japan, 272-0034
      • Ichikawa, Chiba, Japan, 272-0827
    • Fukuoka
      • Kasuga, Fukuoka, Japan, 816-0801
      • Kitakyushu, Fukuoka, Japan, 802-8533
      • Ohnojo, Fukuoka, Japan, 816-0943
    • Hokkaido
      • Otaru, Hokkaido, Japan, 047-0032
      • Sapporo, Hokkaido, Japan, 065-0027
      • Sapporo, Hokkaido, Japan, 006-8555
      • Sapporo, Hokkaido, Japan, 003-0804
      • Sapporo, Hokkaido, Japan, 005-0004
      • Sapporo, Hokkaido, Japan, 005-0842
      • Sapporo, Hokkaido, Japan, 011-0022
      • Sapporo, Hokkaido, Japan, 060-0007
      • Sapporo, Hokkaido, Japan, 063-0804
      • Sapporo, Hokkaido, Japan, 064-0915
    • Ibaragi
      • Tsukuba, Ibaragi, Japan, 305-8576
    • Iwate
      • Hanamaki, Iwate, Japan, 025-0033
    • Kanagawa
      • 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
    • Osaka
      • Moriguchi, Osaka, Japan, 570-8506
      • Osakasayama, Osaka, Japan, 589-8511
      • Osakasayama, Osaka, Japan, 589-0011
      • Sakai, Osaka, Japan, 590-0018
    • Tokyo
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy

Secondary Outcome Measures

Outcome Measure
Difference of total score of HAM-D17 between baseline and final-on-therapy
Remission rate of HAM-D17 at the final-on-therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 23, 2005

Study Record Updates

Last Update Posted (Estimate)

May 28, 2007

Last Update Submitted That Met QC Criteria

May 25, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0600B1-817

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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