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| Sponsor: | Somerset Pharmaceuticals |
|---|---|
| Information provided by: | Somerset Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00531947 |
Purpose
The primary purpose of your participation in this study is to help answer the following research question: Whether 12-week administration of EMSAM (selegiline transdermal system) is safe and effective for the treatment of adolescents (aged 12 through 17 years) with Major Depressive Disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Mental Health Major Depressive Disorder |
Drug: Selegiline Trandermal System Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase IV, Double-Blind, Placebo-Controlled, Randomized, Flexible Dose Study of the Safety and Efficacy of EMSAM in Adolescents With Major Depression |
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Active
Approved Medication for Major Depresive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
|
Drug: Selegiline Trandermal System
EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|
B: Placebo Comparator
Placebo Selegiline Transdermal System 6, 9 or 12
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Thomas Hochadel, Pharm.D. | 727-897-9000 | thochadel@cogres.com |
| Contact: Melissa Goodhead | 800-892-8889 | mlg@somersetpharm.com |
| United States, Alabama | |
| Dr. Nelson Handal | Recruiting |
| Dothan, Alabama, United States | |
| Contact: Nelson Handal, MD 334-836-2000 | |
| United States, California | |
| Dr. Mohammed Bari | Recruiting |
| National City, California, United States | |
| Contact: Mohammed Bari, MD 888-619-7272 | |
| Dr. Michael McManus | Recruiting |
| SanDiego, California, United States | |
| Contact: Michael McManus, MD 858-505-8029 | |
| United States, Florida | |
| Dr. Irving Kolin | Recruiting |
| Winter Park, Florida, United States | |
| Contact: Irving Kolin, MD 407-644-1122 | |
| Dr. Elias Sarkis | Recruiting |
| Gainesville, Florida, United States | |
| Contact: Elias Sarkis, MD 352-333-0094 | |
| Dr. Scott Segal | Recruiting |
| North Miami, Florida, United States | |
| Contact: Scott Segal, MD 877-734-2589 | |
| Dr. Mary Stedman | Recruiting |
| Tampa, Florida, United States | |
| Contact: Mary Stedman, MD 813-971-8311 | |
| United States, Kansas | |
| Dr. Rory Murphy | Recruiting |
| Overland Park, Kansas, United States | |
| Contact: Rory Murphy, MD 913-484-4046 | |
| United States, Kentucky | |
| Dr. Andrew Sediloo | Recruiting |
| Owensboro, Kentucky, United States | |
| Contact: Andrew Sediloo, MD 270-685-4589 | |
| United States, Massachusetts | |
| Dr. Bruce Waslick | Recruiting |
| Springfield, Massachusetts, United States | |
| Contact: Bruce Waslick, MD 413-794-1136 | |
| United States, Nebraska | |
| Dr. Christopher Kratochvil | Recruiting |
| Omaha, Nebraska, United States | |
| Contact: Christopher Kratochvil, MD 402-552-6005 | |
| United States, Nevada | |
| Dr. Ann Childress | Recruiting |
| Las Vegas, Nevada, United States | |
| Contact: Ann Childress, MD 702-838-0742 | |
| United States, Ohio | |
| Dr. Melissa DelBello | Recruiting |
| Cincinnati, Ohio, United States | |
| Contact: Melissa DelBello, MD 513-558-4112 | |
| United States, Oklahoma | |
| Dr. Leland Dennis | Recruiting |
| Oklahoma City, Oklahoma, United States | |
| Contact: Leland Dennis, MD 405-603-8068 | |
| United States, Texas | |
| Dr. David Brown | Recruiting |
| Austin, Texas, United States | |
| Contact: David Brown, MD 866-798-2622 | |
| Dr. Graham Emslie | Recruiting |
| Dallas, Texas, United States | |
| Contact: Graham Emslie, MD 214-456-5900 | |
| Dr. Alain Katic | Recruiting |
| Bellaire, Texas, United States | |
| Contact: Alain Katic, MD 713-665-6446 | |
| United States, Virginia | |
| Dr. John Gilliam | Recruiting |
| Richmond, Virginia, United States | |
| Contact: John Gilliam, MD 804-270-6811 | |
| Dr. Mary Shemo | Recruiting |
| Charlottesville, Virginia, United States | |
| Contact: Mary Shemo, MD 434-984-0005 | |
| United States, Washington | |
| Dr. Arifulla Khan | Recruiting |
| Bellevue, Washington, United States | |
| Contact: Arifulla Khan, MD 877-453-0404 | |
| Study Director: | Thomas Hochadel, Pharm.D. | Cognitive Research Corporation |
| Study Chair: | Melissa L Goodhead | Somerset Pharmaceuticals |
More Information
| Responsible Party: | Somerset Pharmaceuticals, Inc. ( Melissa Goodhead, B.Sc., RAC ) |
| Study ID Numbers: | S9303-P0605 |
| Study First Received: | September 18, 2007 |
| Last Updated: | April 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00531947 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Mental Health Adolescents Major Despressive Disorder |
Depression Adolescent Depression Pediatric Depression |
|
Depression Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Antiparkinson Agents Enzyme Inhibitors Depressive Disorder, Major Depressive Disorder Neuroprotective Agents |
Protective Agents Pharmacologic Actions Behavioral Symptoms Selegiline Mental Disorders Therapeutic Uses Mood Disorders Monoamine Oxidase Inhibitors Central Nervous System Agents |