Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression

October 8, 2008 updated by: University of Pittsburgh
This research study is to evaluate the safety and usefulness of venlafaxine-XR in the treatment of major depression in the elderly.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this pilot study is to evaluate the safety of venlafaxine extended release formulation (XR) in the treatment of geriatric non-psychotic depression. This pilot study's specific aims are to assess the safety of venlafaxine XR in the geriatric population, to estimate the response rate of older depressed subjects treated under open conditions and to evaluate pharmacokinetic characteristics that may impact on safety and outcome.

Study Type

Interventional

Enrollment

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men and women of all races who are 60 years old or older;
  • a DSM-IV diagnosis of major depressive episode without psychotic features;
  • 17-item Ham-D score of >15 for potential subjects who have not received any antidepressant treatment during this illness episode or HAM-D > 11 for potential subjects who have received treatment with an antidepressant (other than venlafaxine-XR) during this illness episode;
  • a MMSE score of >15.

Exclusion Criteria:

  • history of meeting DSM-IV criteria for mania, schizophrenia or other psychotic disorder;
  • history of substance abuse or dependence, including alcohol, within the last three months;
  • current hyponatremia (as defined as a serum sodium level < 130 meq/l);
  • untreated or uncontrolled hypertension;
  • a history of being unable to tolerate venlafaxine-XR or venlafaxine immediate release formulation;
  • history of receiving venlafaxine-XR or venlafaxine immediate release formulation of 6 or more weeks at 300mg/d during index depressive episode; (7) EKG revealing QTc > 480 msec;
  • myocardial infarction, unstable angina, palpitation or cardiogenic syncope within 3 months prior to entering this study;
  • the presence of active suicidal ideation with intent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The safety and tolerability of venlafaxine XR.
Rate of Major Depression remission to treatment.

Secondary Outcome Measures

Outcome Measure
Participant characteristics that influence safety and remission rate.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Benoit H Mulsant, MD, University of Pittsburgh
  • Principal Investigator: Charles F. Reynolds III, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Primary Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

October 9, 2008

Last Update Submitted That Met QC Criteria

October 8, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000918

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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