Clinical trial NCT00225511: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Depression
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-23
Enrollment: 590
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Evaluating Effexor XR for Major Depression.


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

Primary outcomes:
measure: Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy.
Secondary outcomes:
measure: Difference of total score of HAM-D17 between baseline and final-on-therapy.
measure: Remission rate of HAM-D17 at the final-on-therapy.
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Ichikawa
country: Japan
state: Chiba
city: Ichikawa
country: Japan
state: Chiba
city: Kasuga
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Ohnojyo
country: Japan
state: Fukuoka
city: Kure
country: Japan
state: Hiroshima
city: Otaru
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Nishinomiya
country: Japan
state: Hyogo
city: Tsuchiura
country: Japan
state: Ibaragi
city: Tsukuba
country: Japan
state: Ibaragi
city: Kanazawa
country: Japan
state: Ishikawa
city: Hanamaki
country: Japan
state: Iwate
city: Kawasaki
country: Japan
state: Kanagawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Sagamihara
country: Japan
state: Kanagawa
city: Sagamihara
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Kikuchi
country: Japan
state: Kumamoto
city: Ohmura
country: Japan
state: Nagasaki
city: Kashihara
country: Japan
state: Nara
city: Jyo-etsu
country: Japan
state: Niigata
city: Beppu
country: Japan
state: Ohita
city: Moriguchi
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Adachi-ku
country: Japan
state: Tokyo
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Kodaira
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Nakano-ku
country: Japan
state: Tokyo
city: Ohta-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Shinjuku
country: Japan
state: Tokyo
city: Tachikawa
country: Japan
state: Tokyo
city: Toshima-ku
country: Japan
state: Tokyo
city: Toshima-ku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Hiroshima
country: Japan
city: Hiroshima
country: Japan
city: Hiroshima
country: Japan
city: Nagasaki
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: