Safety, Tolerability and Efficacy of the Transdermal System in Elderly Subjects With Major Depression
This study has been completed.
Sponsor:
Somerset Pharmaceuticals
Information provided by:
Somerset Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00285766
First received: January 31, 2006
Last updated: April 21, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression |
Drug: Selegiline Transdermal System |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Somerset Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285766
Locations
| United States, California | |
| Mohammed Bari, M.D. | |
| Chula Vista, California, United States, 91910 | |
| Charles Meredith, M.D. | |
| San Diego, California, United States, 92108 | |
| Daniel Zimbroff, M.D. | |
| Upland, California, United States, 94589 | |
| Kathleen Toups, M.D. | |
| Walnut Creek, California, United States, 94589 | |
| United States, Florida | |
| Abbey Strauss, M.D. | |
| Boynton Beach, Florida, United States, 33437 | |
| Barry Baumel, M.D. | |
| Miami Beach, Florida, United States, 33154 | |
| Mildred Farmer, M.D. | |
| St. Petersburg, Florida, United States, 33710 | |
| Margarita Nunez, M.D. | |
| St. Petersburg, Florida, United States, 33702 | |
| Larry Eisner, M.D. | |
| Tamarack, Florida, United States, 33321 | |
| Andrew Cutler, M.D. | |
| Winter Park, Florida, United States, 32789 | |
| United States, Georgia | |
| Robert Riesenberg, M.D. | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Kentucky | |
| James Hartford, M.D. | |
| Florence, Kentucky, United States, 41042 | |
| United States, Maryland | |
| Mitchel Kling, M.D. | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Oklahoma | |
| Louise Beckett, M.D. | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Texas | |
| Penny Barnhart, M.D. | |
| Wichita Falls, Texas, United States, 76309 | |
Sponsors and Collaborators
Somerset Pharmaceuticals
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00285766 History of Changes |
| Other Study ID Numbers: | S9303-P0204 |
| Study First Received: | January 31, 2006 |
| Last Updated: | April 21, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Somerset Pharmaceuticals:
|
Depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Selegiline Monoamine Oxidase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents Therapeutic Uses Antiparkinson Agents Anti-Dyskinesia Agents |
ClinicalTrials.gov processed this record on June 18, 2013