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Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
This study is currently recruiting participants.
Verified by Somerset Pharmaceuticals, April 2008
First Received: September 18, 2007   Last Updated: April 21, 2008   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Somerset Pharmaceuticals:

Primary Outcome Measures:
  • Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for MDD without psychotic features, single or recurrent [ Time Frame: 24 Months ]

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

Detailed Description:
  • Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for MDD without psychotic features, single or recurrent
  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male / Female outpatients 12 to 17 years of age diagnosed with MDD. (Must have a CDRS-R with a total score of at least 45 at screening.
  • 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 serious or unstable medical illness, psychological condition, clinically significant laboratory or ECG result, hypersensitivity to selegiline, or any other condition that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531947

Contacts
Contact: Thomas Hochadel, Pharm.D. 727-897-9000 thochadel@cogres.com
Contact: Melissa Goodhead 800-892-8889 mlg@somersetpharm.com

Locations
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        
Sponsors and Collaborators
Somerset Pharmaceuticals
Investigators
Study Director: Thomas Hochadel, Pharm.D. Cognitive Research Corporation
Study Chair: Melissa L Goodhead Somerset Pharmaceuticals
  More Information

No publications provided

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

Keywords provided by Somerset Pharmaceuticals:
Mental Health
Adolescents
Major Despressive Disorder
Depression
Adolescent Depression
Pediatric Depression

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009