Study Evaluating Effexor XR in Elderly Patients With Major Depression.

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00225485
First received: September 12, 2005
Last updated: May 25, 2007
Last verified: May 2007
  Purpose

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


Condition Intervention Phase
Depression
Drug: Effexor XR
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase III Study of Effexor XR for the Treatment of Elderly Patients With Depression

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy

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

Estimated Enrollment: 100
Study Start Date: December 2003
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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" of HAM-D at baseline

Exclusion Criteria:

  • Patients with schizophrenia or any other psychotic disorder
  • Patients with history or presence of bipolar disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225485

Locations
Japan
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, 006-8555
Sapporo, Hokkaido, Japan, 005-0004
Sapporo, Hokkaido, Japan, 011-0022
Sapporo, Hokkaido, Japan, 065-0027
Sapporo, Hokkaido, Japan, 064-0915
Sapporo, Hokkaido, Japan, 060-0007
Sapporo, Hokkaido, Japan, 005-0842
Sapporo, Hokkaido, Japan, 063-0804
Sapporo, Hokkaido, Japan, 003-0804
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
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00225485     History of Changes
Other Study ID Numbers: 0600B1-817
Study First Received: September 12, 2005
Last Updated: May 25, 2007
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014