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Study Evaluating Effexor XR for Major Depression.

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: Effexor XR (Drug); Milnacipran (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Summary

Study Evaluating Effexor XR for Major Depression.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Secondary outcome:

Difference of total score of HAM-D17 between baseline and final-on-therapy.

Remission rate of HAM-D17 at the final-on-therapy.

Eligibility

Minimum age: 20 Years. Maximum age: 64 Years. Gender(s): Both.

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

Locations and Contacts

Fukuoka 812-8582, Japan

Fukuoka 810-0801, Japan

Fukuoka 810-0001, Japan

Fukuoka 813-0044, Japan

Hiroshima 730-8518, Japan

Hiroshima 731-0121, Japan

Hiroshima 734-8551, Japan

Nagasaki 852-8501, Japan

Osaka 530-0012, Japan

Osaka 545-8586, Japan

Saitama 330-0074, Japan

Nagoya, Aichi 462-0831, Japan

Nagoya, Aichi 467-8602, Japan

Ichikawa, Chiba 272-0034, Japan

Ichikawa, Chiba 272-0827, Japan

Kasuga, Fukuoka 816-0801, Japan

Kitakyushu, Fukuoka 802-0006, Japan

Kitakyushu, Fukuoka 802-8555, Japan

Kitakyushu, Fukuoka 804-0062, Japan

Kurume, Fukuoka 830-0011, Japan

Ohnojyo, Fukuoka 816-0943, Japan

Kure, Hiroshima 737-0023, Japan

Otaru, Hokkaido 047-0032, Japan

Sapporo, Hokkaido 006-8555, Japan

Sapporo, Hokkaido 060-0042, Japan

Sapporo, Hokkaido 065-0012, Japan

Sapporo, Hokkaido 063-0061, Japan

Sapporo, Hokkaido 064-0946, Japan

Sapporo, Hokkaido 060-8648, Japan

Nishinomiya, Hyogo 662-0832, Japan

Tsuchiura, Ibaragi 300-8585, Japan

Tsukuba, Ibaragi 305-8576, Japan

Kanazawa, Ishikawa 920-8641, Japan

Hanamaki, Iwate 025-0033, Japan

Kawasaki, Kanagawa 215-0021, Japan

Kawasaki, Kanagawa 216-8511, Japan

Sagamihara, Kanagawa 228-0803, Japan

Sagamihara, Kanagawa 229-1103, Japan

Yokohama, Kanagawa 241-0081, Japan

Yokohama, Kanagawa 224-8503, Japan

Yokohama, Kanagawa 225-0012, Japan

Yokohama, Kanagawa 236-0004, Japan

Yokohama, Kanagawa 238-8558, Japan

Yokohama, Kanagawa 220-0004, Japan

Yokohama, Kanagawa 245-8575, Japan

Kikuchi, Kumamoto 861-1116, Japan

Ohmura, Nagasaki 856-8562, Japan

Kashihara, Nara 634-8522, Japan

Jyo-etsu, Niigata 949-3193, Japan

Beppu, Ohita 874-0011, Japan

Moriguchi, Osaka 570-8506, Japan

Osakasayama, Osaka 589-0011, Japan

Osakasayama, Osaka 589-8511, Japan

Hamamatsu, Shizuoka 431-3192, Japan

Adachi-ku, Tokyo 120-0033, Japan

Bunkyo-ku, Tokyo 113-0021, Japan

Bunkyo-ku, Tokyo 113-8603, Japan

Chiyoda-ku, Tokyo 101-8643, Japan

Chiyoda-ku, Tokyo 102-8161, Japan

Itabashi-ku, Tokyo 173-0015, Japan

Kodaira, Tokyo 187-8551, Japan

Meguro-ku, Tokyo 152-0012, Japan

Meguro-ku, Tokyo 152-8902, Japan

Meguro-ku, Tokyo 153-8515, Japan

Minato-ku, Tokyo 107-0052, Japan

Minato-ku, Tokyo 107-0062, Japan

Nakano-ku, Tokyo 164-0003, Japan

Ohta-ku, Tokyo 143-8541, Japan

Setagaya-ku, Tokyo 154-0004, Japan

Shinjuku, Tokyo 160-0023, Japan

Tachikawa, Tokyo 190-0012, Japan

Toshima-ku, Tokyo 170-0002, Japan

Toshima-ku, Tokyo 170-0005, Japan

Additional Information

Starting date: June 2004
Last updated: May 22, 2007

Page last updated: August 23, 2015

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