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

This study has been completed.

Sponsor:

Information provided by:

Somerset Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00285766

First received: January 31, 2006

Last updated: April 21, 2008

Last verified: April 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	January 31, 2006
Last Updated Date	April 21, 2008
Start Date ^ICMJE	August 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00285766 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety, Tolerability and Efficacy of the Transdermal System in Elderly Subjects With Major Depression
Official Title ^ICMJE	A Phase III, Open-Label Study of the Safety, Tolerability and Efficacy of the Selegiline Transdermal System in Elderly Subjects With Major Depression
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Major Depression
Intervention ^ICMJE	Drug: Selegiline Transdermal System
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	300
Completion Date	July 2005
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	65 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00285766
Other Study ID Numbers ^ICMJE	S9303-P0204
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Somerset Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Somerset Pharmaceuticals
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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