Study Evaluating Effexor XR in Elderly Patients With Major Depression.

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00225485

First received: September 12, 2005

Last updated: May 25, 2007

Last verified: May 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

May 25, 2007

Start Date ^ICMJE

December 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00225485 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Effexor XR in Elderly Patients With Major Depression.

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: Effexor XR

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00225485

Other Study ID Numbers ^ICMJE

0600B1-817

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

Information Provided By

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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