Major DepressionPhase 3NCT00285766
Safety, Tolerability and Efficacy of the Transdermal System in Elderly Subjects With Major Depression
A Phase 3 study testing Selegiline Transdermal System in people with Major Depression, run by Somerset Pharmaceuticals at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Major Depression
- What is being tested?
- Selegiline Transdermal System
- How many people
- 300 participants
- Where
- 15 sitesUnited States
- Study dates
- Aug 2002to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
- 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 locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Robert Riesenberg, M.D.
Atlanta, Georgia, 30308
Mitchel Kling, M.D.
Baltimore, Maryland, 21201
Abbey Strauss, M.D.
Boynton Beach, Florida, 33437
Mohammed Bari, M.D.
Chula Vista, California, 91910
James Hartford, M.D.
Florence, Kentucky, 41042
Barry Baumel, M.D.
Miami Beach, Florida, 33154
Louise Beckett, M.D.
Oklahoma City, Oklahoma, 73103
Charles Meredith, M.D.
San Diego, California, 92108
Margarita Nunez, M.D.
St. Petersburg, Florida, 33702
Mildred Farmer, M.D.
St. Petersburg, Florida, 33710
Larry Eisner, M.D.
Tamarack, Florida, 33321
Daniel Zimbroff, M.D.
Upland, California, 94589
Kathleen Toups, M.D.
Walnut Creek, California, 94589
Penny Barnhart, M.D.
Wichita Falls, Texas, 76309
Andrew Cutler, M.D.
Winter Park, Florida, 32789
About this study
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
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.
- Conditions
- Major Depression
- Being tested
- Selegiline Transdermal System
- Keywords
- Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selegiline Transdermal SystemDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startAug 2002
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Somerset Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285766
- Sponsor's protocol ID
- S9303-P0204
- Status last verified
- Apr 2008
- First submitted
- 31 Jan 2006
- Last updated
- 22 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00285766
- Acronym / sponsor ID
- S9303-P0204
- Conditions
- Major Depression
- Keywords
- Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Somerset PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Jul 2005
- First posted
- 2 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selegiline Transdermal System | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selegiline Transdermal System in people with Major Depression, run by Somerset Pharmaceuticals at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2008.