search
Back to results

Study Evaluating Effexor XR in Elderly Patients With Major Depression.

Primary Purpose

Depression

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Effexor XR
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Depression

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference of total score of HAM-D17 between baseline and final-on-therapy
Remission rate of HAM-D17 at the final-on-therapy

Full Information

First Posted
September 12, 2005
Last Updated
May 25, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00225485
Brief Title
Study Evaluating Effexor XR in Elderly Patients With Major Depression.
Official Title
Phase III Study of Effexor XR for the Treatment of Elderly Patients With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Effexor XR
Primary Outcome Measure Information:
Title
Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy
Secondary Outcome Measure Information:
Title
Difference of total score of HAM-D17 between baseline and final-on-therapy
Title
Remission rate of HAM-D17 at the final-on-therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Ichikawa
State/Province
Chiba
ZIP/Postal Code
272-0034
Country
Japan
City
Ichikawa
State/Province
Chiba
ZIP/Postal Code
272-0827
Country
Japan
City
Kasuga
State/Province
Fukuoka
ZIP/Postal Code
816-0801
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8533
Country
Japan
City
Ohnojo
State/Province
Fukuoka
ZIP/Postal Code
816-0943
Country
Japan
City
Otaru
State/Province
Hokkaido
ZIP/Postal Code
047-0032
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
005-0004
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
005-0842
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
011-0022
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0007
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
063-0804
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0915
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
065-0027
Country
Japan
City
Tsukuba
State/Province
Ibaragi
ZIP/Postal Code
305-8576
Country
Japan
City
Hanamaki
State/Province
Iwate
ZIP/Postal Code
025-0033
Country
Japan
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-0063
Country
Japan
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
213-8507
Country
Japan
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-0803
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
224-8503
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
227-8501
Country
Japan
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
570-8506
Country
Japan
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-0011
Country
Japan
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
City
Sakai
State/Province
Osaka
ZIP/Postal Code
590-0018
Country
Japan
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
120-0033
Country
Japan
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8643
Country
Japan
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
183-8524
Country
Japan
City
Higashimurayama
State/Province
Tokyo
ZIP/Postal Code
189-0012
Country
Japan
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-0012
Country
Japan
City
Nakano-ku
State/Province
Tokyo
ZIP/Postal Code
164-0003
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
154-0004
Country
Japan
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0012
Country
Japan
City
Hiroshima
ZIP/Postal Code
731-0121
Country
Japan
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating Effexor XR in Elderly Patients With Major Depression.

We'll reach out to this number within 24 hrs