Study Evaluating Effexor XR for Major Depression.

Phase III Multi-Center, Double-Blind, Comparative Study of Effexor XR for the Treatment of Depression

Study Evaluating Effexor XR for Major Depression.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: Milnacipran; Drug: Effexor XR

• Study Type: Interventional
• Enrollment (Anticipated): 590
• Phase: Phase 3

Contacts and Locations

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, 238-8558
    • Yokohama, Kanagawa, Japan, 241-0081
  • 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

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (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" at the baseline.

Exclusion Criteria:

• Patients with schizophrenia or any other psychotic disorder
• Patients with history or presence of bipolar disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: June 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: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride; Milnacipran; Levomilnacipran
• Other Study ID Numbers: 0600B1-816