Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
A Phase IV, Double-Blind, Placebo-Controlled, Randomized, Flexible Dose Study of the Safety and Efficacy of EMSAM in Adolescents With Major Depression
1 other identifier
interventional
308
1 country
20
Brief Summary
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 (MDD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started Jul 2007
Typical duration for phase_4 major-depressive-disorder
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 18, 2007
CompletedFirst Posted
Study publicly available on registry
September 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
June 26, 2013
CompletedJanuary 15, 2014
December 1, 2013
3.3 years
September 18, 2007
December 27, 2012
December 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12
A summary of the primary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score, as reported by the Child, at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time. CDRS-R total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior.
baseline and 12 Weeks
Secondary Outcomes (18)
CGI-S - Week 12 (mITT w/LOCF Population)
Baseline and 12 Weeks
CGI-C - Week 12 (mITT w/LOCF Population)
12 Weeks
CGI-C Percent Responders (mITT w/LOCF Population)
12 Weeks
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)
Baseline and 12 Weeks
CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)
12 Weeks
- +13 more secondary outcomes
Study Arms (2)
EMSAM
EXPERIMENTALApproved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Placebo
PLACEBO COMPARATORPlacebo Selegiline Transdermal System 6, 9 or 12
Interventions
EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Eligibility Criteria
You may qualify if:
- Male / Female outpatients 12 to 17 years of age diagnosed with Major Depressive Disorder (MDD). (Must have a Children's Depression Rating Scale-Revised \[CDRS-R\] 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kim Portland, Ph.D.
- Organization
- Mylan Specialty L.P.
Study Officials
- STUDY DIRECTOR
Thomas Hochadel, Pharm.D.
Cognitive Research Corporation
- STUDY CHAIR
Melissa L Goodhead
Somerset Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2007
First Posted
September 19, 2007
Study Start
July 1, 2007
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
January 15, 2014
Results First Posted
June 26, 2013
Record last verified: 2013-12