Safety, Tolerability and Efficacy of the 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.

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Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mohammed Bari, M.D., Chula Vista, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selegiline Transdermal System

Drug

Sponsors and collaborators

Lead sponsor

Somerset Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Study completion: 2005
First posted: Feb 2, 2006
Registry last updated: Apr 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed