MedDataX Logo

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

NCT ID: NCT00285766

Last Updated: 2008-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2005-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depression

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Selegiline Transdermal System

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Somerset Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mohammed Bari, M.D.

Chula Vista, California, United States

Site Status

Charles Meredith, M.D.

San Diego, California, United States

Site Status

Daniel Zimbroff, M.D.

Upland, California, United States

Site Status

Kathleen Toups, M.D.

Walnut Creek, California, United States

Site Status

Abbey Strauss, M.D.

Boynton Beach, Florida, United States

Site Status

Barry Baumel, M.D.

Miami Beach, Florida, United States

Site Status

Margarita Nunez, M.D.

St. Petersburg, Florida, United States

Site Status

Mildred Farmer, M.D.

St. Petersburg, Florida, United States

Site Status

Larry Eisner, M.D.

Tamarack, Florida, United States

Site Status

Andrew Cutler, M.D.

Winter Park, Florida, United States

Site Status

Robert Riesenberg, M.D.

Atlanta, Georgia, United States

Site Status

James Hartford, M.D.

Florence, Kentucky, United States

Site Status

Mitchel Kling, M.D.

Baltimore, Maryland, United States

Site Status

Louise Beckett, M.D.

Oklahoma City, Oklahoma, United States

Site Status

Penny Barnhart, M.D.

Wichita Falls, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S9303-P0204

Identifier Type: -

Identifier Source: org_study_id