Clinical trial NCT00225524: Study Evaluating Long-Term Safety of Effexor XR in Patients With Major Depression.
Official title: Phase III Long-Term Administration 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: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events
Secondary outcomes:
measure: Quantitative data for laboratory data
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: Yokosuka
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: