NCT00225524

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 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

September 1, 2004

Completed
1 year 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)

  • Incidence of adverse events

Secondary Outcomes (1)

  • Quantitative data for laboratory data

Interventions

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who complete the Phase III double-blind study (Protocol Number 0600B1-816)

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

Location

Unknown Facility

Ichikawa, Chiba, 272-0034, Japan

Location

Unknown Facility

Ichikawa, Chiba, 272-0827, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 810-0001, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 810-0801, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 812-8582, Japan

Location

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

Location

Unknown Facility

Kure, Hiroshima, 737-0023, Japan

Location

Unknown Facility

Otaru, Hokkaido, 047-0032, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 006-8555, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 060-0042, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 060-8648, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 063-0061, Japan

Location

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

Location

Unknown Facility

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Unknown Facility

Hanamaki, Iwate, 025-0033, Japan

Location

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

Location

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, 241-0081, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 245-8575, Japan

Location

Unknown Facility

Yokosuka, Kanagawa, 238-8558, 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 Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

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
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 23, 2005

Study Start

September 1, 2004

Last Updated

May 24, 2007

Record last verified: 2007-05

Locations