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

Somerset Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Major Depression

Treatments: Drug: Selegiline Transdermal System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00285766

S9303-P0204

Details and patient eligibility

About

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.

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)