NCT00225485

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 depression

Geographic Reach
1 country

37 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

December 1, 2003

Completed
1.8 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 28, 2007

Status Verified

May 1, 2007

First QC Date

September 12, 2005

Last Update Submit

May 25, 2007

Conditions

Depression

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

Effexor XRDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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" of HAM-D at 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 (37)

Unknown Facility

Ichikawa, Chiba, 272-0034, Japan

Location

Unknown Facility

Ichikawa, Chiba, 272-0827, Japan

Location

Unknown Facility

Kasuga, Fukuoka, 816-0801, Japan

Location

Unknown Facility

Kitakyushu, Fukuoka, 802-8533, Japan

Location

Unknown Facility

Ohnojo, Fukuoka, 816-0943, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, 731-0121, Japan

Location

Unknown Facility

Otaru, Hokkaido, 047-0032, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 003-0804, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 005-0004, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 005-0842, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 006-8555, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 011-0022, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 060-0007, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 063-0804, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 064-0915, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 065-0027, Japan

Location

Unknown Facility

Tsukuba, Ibaragi, 305-8576, Japan

Location

Unknown Facility

Hanamaki, Iwate, 025-0033, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, 211-0063, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, 213-8507, Japan

Location

Unknown Facility

Sagamihara, Kanagawa, 228-0803, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 224-8503, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 227-8501, Japan

Location

Unknown Facility

Okayama, Okayama-ken, 700-8558, Japan

Location

Unknown Facility

Moriguchi, Osaka, 570-8506, Japan

Location

Unknown Facility

Sakai, Osaka, 590-0018, Japan

Location

Unknown Facility

Sayama, Osaka, 589-0011, Japan

Location

Unknown Facility

Sayama, Osaka, 589-8511, Japan

Location

Unknown Facility

Adachi-ku, Tokyo, 120-0033, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, 101-8643, Japan

Location

Unknown Facility

Fuchū, Tokyo, 183-8524, Japan

Location

Unknown Facility

Higashimurayama, Tokyo, 189-0012, Japan

Location

Unknown Facility

Kodaira, Tokyo, 187-8551, Japan

Location

Unknown Facility

Meguro-ku, Tokyo, 152-0012, Japan

Location

Unknown Facility

Nakano-ku, Tokyo, 164-0003, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, 154-0004, Japan

Location

Unknown Facility

Tachikawa, Tokyo, 190-0012, 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
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 23, 2005

Study Start

December 1, 2003

Last Updated

May 28, 2007

Record last verified: 2007-05

Locations

JP(37)