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

May 22, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Phase III Long-Term Administration Study of Effexor XR for the Treatment of Depression

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

Study Overview

Status

Completed

Conditions

Depression

Intervention / Treatment

Drug: Effexor XR

Study Type

Interventional

Enrollment (Anticipated)

150

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
- - Fukuoka, Japan, 813-0044
  - Fukuoka, Japan, 810-0001
  - Fukuoka, Japan, 812-8582
  - Fukuoka, Japan, 810-0801
  - Hiroshima, Japan, 734-8551
  - Hiroshima, Japan, 730-8518
  - Hiroshima, Japan, 731-0121
  - Nagasaki, Japan, 852-8501
  - Osaka, Japan, 545-8586
  - Osaka, Japan, 530-0012
  - Saitama, Japan, 330-0074
- Aichi
  - Nagoya, Aichi, Japan, 467-8602
  - Nagoya, Aichi, Japan, 462-0831
- Chiba
  - Ichikawa, Chiba, Japan, 272-0034
  - Ichikawa, Chiba, Japan, 272-0827
- Fukuoka
  - Kasuga, Fukuoka, Japan, 816-0801
  - Kitakyushu, Fukuoka, Japan, 802-8555
  - Kitakyushu, Fukuoka, Japan, 802-0006
  - Kitakyushu, Fukuoka, Japan, 804-0062
  - Kurume, Fukuoka, Japan, 830-0011
  - Ohnojyo, Fukuoka, Japan, 816-0943
- Hiroshima
  - Kure, Hiroshima, Japan, 737-0023
- Hokkaido
  - Otaru, Hokkaido, Japan, 047-0032
  - Sapporo, Hokkaido, Japan, 006-8555
  - Sapporo, Hokkaido, Japan, 060-8648
  - Sapporo, Hokkaido, Japan, 060-0042
  - Sapporo, Hokkaido, Japan, 063-0061
  - Sapporo, Hokkaido, Japan, 064-0946
  - Sapporo, Hokkaido, Japan, 065-0012
- Hyogo
  - Nishinomiya, Hyogo, Japan, 662-0832
- Ibaragi
  - Tsuchiura, Ibaragi, Japan, 300-8585
  - Tsukuba, Ibaragi, Japan, 305-8576
- Ishikawa
  - Kanazawa, Ishikawa, Japan, 920-8641
- Iwate
  - Hanamaki, Iwate, Japan, 025-0033
- Kanagawa
  - Kawasaki, Kanagawa, Japan, 216-8511
  - Kawasaki, Kanagawa, Japan, 215-0021
  - Sagamihara, Kanagawa, Japan, 228-0803
  - Sagamihara, Kanagawa, Japan, 229-1103
  - Yokohama, Kanagawa, Japan, 245-8575
  - Yokohama, Kanagawa, Japan, 236-0004
  - Yokohama, Kanagawa, Japan, 220-0004
  - Yokohama, Kanagawa, Japan, 224-8503
  - Yokohama, Kanagawa, Japan, 225-0012
  - Yokohama, Kanagawa, Japan, 241-0081
  - Yokosuka, Kanagawa, Japan, 238-8558
- Kumamoto
  - Kikuchi, Kumamoto, Japan, 861-1116
- Nagasaki
  - Ohmura, Nagasaki, Japan, 856-8562
- Nara
  - Kashihara, Nara, Japan, 634-8522
- Niigata
  - Jyo-etsu, Niigata, Japan, 949-3193
- Ohita
  - Beppu, Ohita, Japan, 874-0011
- Osaka
  - Moriguchi, Osaka, Japan, 570-8506
  - Osakasayama, Osaka, Japan, 589-8511
  - Osakasayama, Osaka, Japan, 589-0011
- Shizuoka
  - Hamamatsu, Shizuoka, Japan, 431-3192
- Tokyo
  - Adachi-ku, Tokyo, Japan, 120-0033
  - Bunkyo-ku, Tokyo, Japan, 113-0021
  - Bunkyo-ku, Tokyo, Japan, 113-8603
  - Chiyoda-ku, Tokyo, Japan, 101-8643
  - Chiyoda-ku, Tokyo, Japan, 102-8161
  - Itabashi-ku, Tokyo, Japan, 173-0015
  - Kodaira, Tokyo, Japan, 187-8551
  - Meguro-ku, Tokyo, Japan, 153-8515
  - Meguro-ku, Tokyo, Japan, 152-8902
  - Meguro-ku, Tokyo, Japan, 152-0012
  - Minato-ku, Tokyo, Japan, 107-0052
  - Minato-ku, Tokyo, Japan, 107-0062
  - Nakano-ku, Tokyo, Japan, 164-0003
  - Ohta-ku, Tokyo, Japan, 143-8541
  - Setagaya-ku, Tokyo, Japan, 154-0004
  - Shinjuku, Tokyo, Japan, 160-0023
  - Tachikawa, Tokyo, Japan, 190-0012
  - Toshima-ku, Tokyo, Japan, 170-0002
  - Toshima-ku, Tokyo, Japan, 170-0005

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

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: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of adverse events

Secondary Outcome Measures

Outcome Measure
Quantitative data for laboratory data

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

September 1, 2004

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 24, 2007

Last Update Submitted That Met QC Criteria

May 22, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Depression

Additional Relevant MeSH Terms

Other Study ID Numbers

0600B1-818

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.