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Study Evaluating Effexor XR for Major Depression.

Primary Purpose

Depression

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Effexor XR
Milnacipran
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

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.

Full Information

First Posted
September 12, 2005
Last Updated
May 22, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00225511
Brief Title
Study Evaluating Effexor XR for Major Depression.
Official Title
Phase III Multi-Center, Double-Blind, Comparative Study of Effexor XR for the Treatment of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary
Study Evaluating Effexor XR for Major Depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Non-Randomized
Enrollment
590 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Effexor XR
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Primary Outcome Measure Information:
Title
Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy.
Secondary Outcome Measure Information:
Title
Difference of total score of HAM-D17 between baseline and final-on-therapy.
Title
Remission rate of HAM-D17 at the final-on-therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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" at the baseline. Exclusion Criteria: Patients with schizophrenia or any other psychotic disorder Patients with history or presence of bipolar disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
462-0831
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
City
Ichikawa
State/Province
Chiba
ZIP/Postal Code
272-0034
Country
Japan
City
Ichikawa
State/Province
Chiba
ZIP/Postal Code
272-0827
Country
Japan
City
Kasuga
State/Province
Fukuoka
ZIP/Postal Code
816-0801
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-0006
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
804-0062
Country
Japan
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
City
Ohnojyo
State/Province
Fukuoka
ZIP/Postal Code
816-0943
Country
Japan
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
City
Otaru
State/Province
Hokkaido
ZIP/Postal Code
047-0032
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0042
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
063-0061
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0946
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
065-0012
Country
Japan
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
662-0832
Country
Japan
City
Tsuchiura
State/Province
Ibaragi
ZIP/Postal Code
300-8585
Country
Japan
City
Tsukuba
State/Province
Ibaragi
ZIP/Postal Code
305-8576
Country
Japan
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
City
Hanamaki
State/Province
Iwate
ZIP/Postal Code
025-0033
Country
Japan
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
215-0021
Country
Japan
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-0803
Country
Japan
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
229-1103
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
220-0004
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
224-8503
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
225-0012
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
238-8558
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-0081
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
City
Kikuchi
State/Province
Kumamoto
ZIP/Postal Code
861-1116
Country
Japan
City
Ohmura
State/Province
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
City
Jyo-etsu
State/Province
Niigata
ZIP/Postal Code
949-3193
Country
Japan
City
Beppu
State/Province
Ohita
ZIP/Postal Code
874-0011
Country
Japan
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
570-8506
Country
Japan
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-0011
Country
Japan
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
120-0033
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-0021
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8643
Country
Japan
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
102-8161
Country
Japan
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-0015
Country
Japan
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-0012
Country
Japan
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
107-0052
Country
Japan
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
107-0062
Country
Japan
City
Nakano-ku
State/Province
Tokyo
ZIP/Postal Code
164-0003
Country
Japan
City
Ohta-ku
State/Province
Tokyo
ZIP/Postal Code
143-8541
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
154-0004
Country
Japan
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0012
Country
Japan
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
170-0002
Country
Japan
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
170-0005
Country
Japan
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
City
Fukuoka
ZIP/Postal Code
810-0801
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Fukuoka
ZIP/Postal Code
813-0044
Country
Japan
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
City
Hiroshima
ZIP/Postal Code
731-0121
Country
Japan
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
City
Osaka
ZIP/Postal Code
530-0012
Country
Japan
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
City
Saitama
ZIP/Postal Code
330-0074
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating Effexor XR for Major Depression.

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