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

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Selegiline Transdermal System
Sponsored by
Somerset Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Depression

Eligibility Criteria

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

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

Sites / Locations

  • Mohammed Bari, M.D.
  • Charles Meredith, M.D.
  • Daniel Zimbroff, M.D.
  • Kathleen Toups, M.D.
  • Abbey Strauss, M.D.
  • Barry Baumel, M.D.
  • Margarita Nunez, M.D.
  • Mildred Farmer, M.D.
  • Larry Eisner, M.D.
  • Andrew Cutler, M.D.
  • Robert Riesenberg, M.D.
  • James Hartford, M.D.
  • Mitchel Kling, M.D.
  • Louise Beckett, M.D.
  • Penny Barnhart, M.D.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 31, 2006
Last Updated
April 21, 2008
Sponsor
Somerset Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00285766
Brief Title
Safety, Tolerability and Efficacy of the Transdermal System in Elderly Subjects With Major Depression
Official Title
A Phase III, Open-Label Study of the Safety, Tolerability and Efficacy of the Selegiline Transdermal System in Elderly Subjects With Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Somerset Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Selegiline Transdermal System

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mohammed Bari, M.D.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Charles Meredith, M.D.
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Daniel Zimbroff, M.D.
City
Upland
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Kathleen Toups, M.D.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Abbey Strauss, M.D.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Barry Baumel, M.D.
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33154
Country
United States
Facility Name
Margarita Nunez, M.D.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
Mildred Farmer, M.D.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Larry Eisner, M.D.
City
Tamarack
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Andrew Cutler, M.D.
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Robert Riesenberg, M.D.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
James Hartford, M.D.
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
Mitchel Kling, M.D.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Louise Beckett, M.D.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Penny Barnhart, M.D.
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States

12. IPD Sharing Statement

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

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