Safety, Tolerability and Efficacy of the Transdermal System in Elderly Subjects With Major Depression

April 21, 2008 updated by: Somerset Pharmaceuticals

A Phase III, Open-Label Study of the Safety, Tolerability and Efficacy of the Selegiline Transdermal System in Elderly Subjects With Major Depression

Objective of this 16-week, open-label study is to assess the safety and tolerability of once daily application of three doses of STS during continuous dosing in the treatment of elderly subjects with major depression. Subjects will have study visits (clinic visits) at beginning of study (baseline) and study weeks 1, 3, 5, 8, 12, and 16.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

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
    • California
      • Chula Vista, California, United States, 91910
        • Mohammed Bari, M.D.
      • San Diego, California, United States, 92108
        • Charles Meredith, M.D.
      • Upland, California, United States, 94589
        • Daniel Zimbroff, M.D.
      • Walnut Creek, California, United States, 94589
        • Kathleen Toups, M.D.
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Abbey Strauss, M.D.
      • Miami Beach, Florida, United States, 33154
        • Barry Baumel, M.D.
      • St. Petersburg, Florida, United States, 33702
        • Margarita Nunez, M.D.
      • St. Petersburg, Florida, United States, 33710
        • Mildred Farmer, M.D.
      • Tamarack, Florida, United States, 33321
        • Larry Eisner, M.D.
      • Winter Park, Florida, United States, 32789
        • Andrew Cutler, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Robert Riesenberg, M.D.
    • Kentucky
      • Florence, Kentucky, United States, 41042
        • James Hartford, M.D.
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Mitchel Kling, M.D.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Louise Beckett, M.D.
    • Texas
      • Wichita Falls, Texas, United States, 76309
        • Penny Barnhart, M.D.

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

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Men/Women in good health 65 years or older
  • Ability to read, understand and sign study informed consent
  • Major depression- mild to severe based on rating scale

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)

Collaborators and Investigators

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

Sponsor

Somerset Pharmaceuticals

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

August 1, 2002

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 2, 2006

Study Record Updates

Last Update Posted (Estimate)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 21, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S9303-P0204

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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