Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression - Full Text View

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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:

MedlinePlus related topics: Child Mental Health Depression Mental Health

Drug Information available for: Selegiline Selegiline hydrochloride

U.S. FDA Resources

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
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

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 Other Name: EMSAM
Placebo Comparator: B 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

Locations

United States, Alabama
Dr. Nelson Handal
Dothan, Alabama, United States
United States, California
Dr. Mohammed Bari
National City, California, United States
Dr. Michael McManus
SanDiego, California, United States
United States, Florida
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
United States, Kansas
Dr. Rory Murphy
Overland Park, Kansas, United States
United States, Kentucky
Dr. Andrew Sediloo
Owensboro, Kentucky, United States
United States, Massachusetts
Dr. Bruce Waslick
Springfield, Massachusetts, United States
United States, Nebraska
Dr. Christopher Kratochvil
Omaha, Nebraska, United States
United States, Nevada
Dr. Ann Childress
Las Vegas, Nevada, United States
United States, Ohio
Dr. Melissa DelBello
Cincinnati, Ohio, United States
United States, Oklahoma
Dr. Leland Dennis
Oklahoma City, Oklahoma, United States
United States, Texas
Dr. David Brown
Austin, Texas, United States
Dr. Alain Katic
Bellaire, Texas, United States
Dr. Graham Emslie
Dallas, Texas, United States
United States, Virginia
Dr. Mary Shemo
Charlottesville, Virginia, United States
Dr. John Gilliam
Richmond, Virginia, United States
United States, Washington
Dr. Arifulla Khan
Bellevue, Washington, United States

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:	Melissa Goodhead, B.Sc., RAC, Somerset Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00531947 History of Changes
Other Study ID Numbers:	S9303-P0605
Study First Received:	September 18, 2007
Last Updated:	February 28, 2011
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
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Selegiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on February 12, 2012