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Study Evaluating Effexor XR in Elderly Patients With Major Depression.

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: Effexor XR (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

Phase III study evaluating Effexor XR in elderly patients with major depression.

Clinical Details

Official title: Phase III Study of Effexor XR for the Treatment of Elderly Patients With Depression

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

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: 65 Years. Maximum age: N/A. 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" of HAM-D at baseline Exclusion Criteria:

- Patients with schizophrenia or any other psychotic disorder

- Patients with history or presence of bipolar disorder

Locations and Contacts

Hiroshima 731-0121, Japan

Okayama 700-8558, Japan

Ichikawa, Chiba 272-0034, Japan

Ichikawa, Chiba 272-0827, Japan

Kasuga, Fukuoka 816-0801, Japan

Kitakyushu, Fukuoka 802-8533, Japan

Ohnojo, Fukuoka 816-0943, Japan

Otaru, Hokkaido 047-0032, Japan

Sapporo, Hokkaido 006-8555, Japan

Sapporo, Hokkaido 005-0004, Japan

Sapporo, Hokkaido 005-0842, Japan

Sapporo, Hokkaido 065-0027, Japan

Sapporo, Hokkaido 011-0022, Japan

Sapporo, Hokkaido 060-0007, Japan

Sapporo, Hokkaido 063-0804, Japan

Sapporo, Hokkaido 003-0804, Japan

Sapporo, Hokkaido 064-0915, Japan

Tsukuba, Ibaragi 305-8576, Japan

Hanamaki, Iwate 025-0033, Japan

Kawasaki, Kanagawa 213-8507, Japan

Kawasaki, Kanagawa 211-0063, Japan

Sagamihara, Kanagawa 228-0803, Japan

Yokohama, Kanagawa 224-8503, Japan

Yokohama, Kanagawa 227-8501, Japan

Moriguchi, Osaka 570-8506, Japan

Osakasayama, Osaka 589-0011, Japan

Osakasayama, Osaka 589-8511, Japan

Sakai, Osaka 590-0018, Japan

Adachi-ku, Tokyo 120-0033, Japan

Chiyoda-ku, Tokyo 101-8643, Japan

Fuchu, Tokyo 183-8524, Japan

Higashimurayama, Tokyo 189-0012, Japan

Kodaira, Tokyo 187-8551, Japan

Meguro-ku, Tokyo 152-0012, Japan

Nakano-ku, Tokyo 164-0003, Japan

Setagaya-ku, Tokyo 154-0004, Japan

Tachikawa, Tokyo 190-0012, Japan

Additional Information

Starting date: December 2003
Last updated: May 25, 2007

Page last updated: August 20, 2015

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