NCT00225511

Brief Summary

Study Evaluating Effexor XR for Major Depression.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
590

participants targeted

Target at P75+ for phase_3 depression

Geographic Reach
1 country

73 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
Last Updated

May 24, 2007

Status Verified

May 1, 2007

First QC Date

September 12, 2005

Last Update Submit

May 22, 2007

Conditions

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

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

Interventions

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with schizophrenia or any other psychotic disorder
  • Patients with history or presence of bipolar disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (73)

Unknown Facility

Nagoya, Aichi-ken, 462-0831, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 467-8602, Japan

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Unknown Facility

Ichikawa, Chiba, 272-0034, Japan

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Unknown Facility

Ichikawa, Chiba, 272-0827, Japan

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Unknown Facility

Fukuoka, Fukuoka, 810-0001, Japan

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Unknown Facility

Fukuoka, Fukuoka, 810-0801, Japan

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Unknown Facility

Fukuoka, Fukuoka, 812-8582, Japan

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Unknown Facility

Fukuoka, Fukuoka, 813-0044, Japan

Location

Unknown Facility

Kasuga, Fukuoka, 816-0801, Japan

Location

Unknown Facility

Kitakyushu, Fukuoka, 802-0006, Japan

Location

Unknown Facility

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Unknown Facility

Kitakyushu, Fukuoka, 804-0062, Japan

Location

Unknown Facility

Kurume, Fukuoka, 830-0011, Japan

Location

Unknown Facility

Ohnojyo, Fukuoka, 816-0943, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, 730-8518, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, 731-0121, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, 734-8551, Japan

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Unknown Facility

Kure, Hiroshima, 737-0023, Japan

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Unknown Facility

Otaru, Hokkaido, 047-0032, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 006-8555, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 060-0042, Japan

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Unknown Facility

Sapporo, Hokkaido, 060-8648, Japan

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Unknown Facility

Sapporo, Hokkaido, 063-0061, Japan

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Unknown Facility

Sapporo, Hokkaido, 064-0946, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 065-0012, Japan

Location

Unknown Facility

Nishinomiya, Hyōgo, 662-0832, Japan

Location

Unknown Facility

Tsuchiura, Ibaragi, 300-8585, Japan

Location

Unknown Facility

Tsukuba, Ibaragi, 305-8576, Japan

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Kanazawa, Ishikawa-ken, 920-8641, Japan

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Hanamaki, Iwate, 025-0033, Japan

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Unknown Facility

Kawasaki, Kanagawa, 215-0021, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, 216-8511, Japan

Location

Unknown Facility

Sagamihara, Kanagawa, 228-0803, Japan

Location

Unknown Facility

Sagamihara, Kanagawa, 229-1103, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 220-0004, Japan

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Unknown Facility

Yokohama, Kanagawa, 224-8503, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 225-0012, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 236-0004, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 238-8558, Japan

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Unknown Facility

Yokohama, Kanagawa, 241-0081, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 245-8575, Japan

Location

Unknown Facility

Kikuchi, Kumamoto, 861-1116, Japan

Location

Unknown Facility

Nagasaki, Nagasaki, 852-8501, Japan

Location

Unknown Facility

Ohmura, Nagasaki, 856-8562, Japan

Location

Unknown Facility

Kashihara, Nara, 634-8522, Japan

Location

Unknown Facility

Jyo-etsu, Niigata, 949-3193, Japan

Location

Unknown Facility

Beppu, Ohita, 874-0011, Japan

Location

Unknown Facility

Moriguchi, Osaka, 570-8506, Japan

Location

Unknown Facility

Osaka, Osaka, 530-0012, Japan

Location

Unknown Facility

Osaka, Osaka, 545-8586, Japan

Location

Unknown Facility

Sayama, Osaka, 589-0011, Japan

Location

Unknown Facility

Sayama, Osaka, 589-8511, Japan

Location

Unknown Facility

Saitama, Saitama, 330-0074, Japan

Location

Unknown Facility

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Unknown Facility

Adachi-ku, Tokyo, 120-0033, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-0021, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, 101-8643, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, 102-8161, Japan

Location

Unknown Facility

Itabashi-ku, Tokyo, 173-0015, Japan

Location

Unknown Facility

Kodaira, Tokyo, 187-8551, Japan

Location

Unknown Facility

Meguro-ku, Tokyo, 152-0012, Japan

Location

Unknown Facility

Meguro-ku, Tokyo, 152-8902, Japan

Location

Unknown Facility

Meguro-ku, Tokyo, 153-8515, Japan

Location

Unknown Facility

Minato-ku, Tokyo, 107-0052, Japan

Location

Unknown Facility

Minato-ku, Tokyo, 107-0062, Japan

Location

Unknown Facility

Nakano-ku, Tokyo, 164-0003, Japan

Location

Unknown Facility

Ohta-ku, Tokyo, 143-8541, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, 154-0004, Japan

Location

Unknown Facility

Shinjuku, Tokyo, 160-0023, Japan

Location

Unknown Facility

Tachikawa, Tokyo, 190-0012, Japan

Location

Unknown Facility

Toshima-ku, Tokyo, 170-0002, Japan

Location

Unknown Facility

Toshima-ku, Tokyo, 170-0005, Japan

Location

MeSH Terms

Conditions

Depression

Interventions

Venlafaxine HydrochlorideMilnacipran

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipidsCyclopropanes

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 23, 2005

Study Start

June 1, 2004

Last Updated

May 24, 2007

Record last verified: 2007-05

Locations