Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
NCT ID: NCT00531947
Last Updated: 2014-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
308 participants
INTERVENTIONAL
2007-07-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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EMSAM
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System
EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Placebo
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo
Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Interventions
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Selegiline Transdermal System
EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Placebo
Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female patients must test negative on a pregnancy at visit 1.
* Weight and height must be greater than the 10th percentile according to age and height,
* Assent and consent must be given.
Exclusion Criteria
* Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator.
* Have a risk of suicide
* Female patients who are either pregnant, nursing or have recently given birth.
* Use of any protocol prohibited medications or substances.
12 Years
17 Years
ALL
No
Sponsors
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Somerset Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Hochadel, Pharm.D.
Role: STUDY_DIRECTOR
Cognitive Research Corporation
Melissa L Goodhead
Role: STUDY_CHAIR
Somerset Pharmaceuticals
Locations
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Dr. Nelson Handal
Dothan, Alabama, United States
Dr. Mohammed Bari
National City, California, United States
Dr. Michael McManus
San Diego, California, United States
Dr. Elias Sarkis
Gainesville, Florida, United States
Dr. Scott Segal
North Miami, Florida, United States
Dr. Mary Stedman
Tampa, Florida, United States
Dr. Irving Kolin
Winter Park, Florida, United States
Dr. Rory Murphy
Overland Park, Kansas, United States
Dr. Andrew Sediloo
Owensboro, Kentucky, United States
Dr. Bruce Waslick
Springfield, Massachusetts, United States
Dr. Christopher Kratochvil
Omaha, Nebraska, United States
Dr. Ann Childress
Las Vegas, Nevada, United States
Dr. Melissa DelBello
Cincinnati, Ohio, United States
Dr. Leland Dennis
Oklahoma City, Oklahoma, United States
Dr. David Brown
Austin, Texas, United States
Dr. Alain Katic
Bellaire, Texas, United States
Dr. Graham Emslie
Dallas, Texas, United States
Dr. Mary Shemo
Charlottesville, Virginia, United States
Dr. John Gilliam
Richmond, Virginia, United States
Dr. Arifulla Khan
Bellevue, Washington, United States
Countries
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Other Identifiers
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S9303-P0605
Identifier Type: -
Identifier Source: org_study_id
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