Clinical trial NCT00531947: Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Mental Health
Adolescents
Major Depressive Disorder
Depression
Adolescent Depression
Pediatric Depression
Lead sponsor: Somerset Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-09-19
Enrollment: 308
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 Major Depressive Disorder (MDD) without psychotic features, single or recurrent

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12
timeFrame: baseline and 12 Weeks
Secondary outcomes:
measure: CGI-S - Week 12 (mITT w/LOCF Population)
timeFrame: Baseline and 12 Weeks
measure: CGI-C - Week 12 (mITT w/LOCF Population)
timeFrame: 12 Weeks
measure: CGI-C Percent Responders (mITT w/LOCF Population)
timeFrame: 12 Weeks
measure: CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)
timeFrame: Baseline and 12 Weeks
measure: CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)
timeFrame: 12 Weeks
measure: CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)
timeFrame: 12 Weeks
measure: CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)
timeFrame: 12 Weeks
measure: CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)
timeFrame: 12 Weeks
measure: Physical Examination (Screening vs. EOS)
timeFrame: 12 Weeks
measure: Urinalysis (Change From Baseline)
timeFrame: 12 Weeks
measure: Vital Signs-Heart Rate (Change From Baseline)
timeFrame: 12 Weeks
measure: Vital Signs-Blood Pressure (Change From Baseline)
timeFrame: 12 Weeks
measure: 12 Lead ECG (Change From Baseline)
timeFrame: 12 Weeks
measure: 12 Lead ECG (Change From Baseline)Ventricular Heart Rate
timeFrame: 12 Weeks
measure: Hematology - White Blood Cell (WBC) (Change From Baseline)
timeFrame: 12 Weeks
measure: Hematology - Hematocrit (Change From Baseline)
timeFrame: 12 Weeks
measure: Hematology - Hemoglobin (Change From Baseline)
timeFrame: 12 Weeks
measure: Hematology - Red Blood Cell (Change From Baseline)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Dr. Nelson Handal
state: Alabama
city: National City
country: United States
facility: Dr. Mohammed Bari
state: California
city: SanDiego
country: United States
facility: Dr. Michael McManus
state: California
city: Gainesville
country: United States
facility: Dr. Elias Sarkis
state: Florida
city: North Miami
country: United States
facility: Dr. Scott Segal
state: Florida
city: Tampa
country: United States
facility: Dr. Mary Stedman
state: Florida
city: Winter Park
country: United States
facility: Dr. Irving Kolin
state: Florida
city: Overland Park
country: United States
facility: Dr. Rory Murphy
state: Kansas
city: Owensboro
country: United States
facility: Dr. Andrew Sediloo
state: Kentucky
city: Springfield
country: United States
facility: Dr. Bruce Waslick
state: Massachusetts
city: Omaha
country: United States
facility: Dr. Christopher Kratochvil
state: Nebraska
city: Las Vegas
country: United States
facility: Dr. Ann Childress
state: Nevada
city: Cincinnati
country: United States
facility: Dr. Melissa DelBello
state: Ohio
city: Oklahoma City
country: United States
facility: Dr. Leland Dennis
state: Oklahoma
city: Austin
country: United States
facility: Dr. David Brown
state: Texas
city: Bellaire
country: United States
facility: Dr. Alain Katic
state: Texas
city: Dallas
country: United States
facility: Dr. Graham Emslie
state: Texas
city: Charlottesville
country: United States
facility: Dr. Mary Shemo
state: Virginia
city: Richmond
country: United States
facility: Dr. John Gilliam
state: Virginia
city: Bellevue
country: United States
facility: Dr. Arifulla Khan
state: Washington
Study officials:
affiliation: Cognitive Research Corporation
name: Thomas Hochadel, Pharm.D.
role: STUDY_DIRECTOR
affiliation: Somerset Pharmaceuticals
name: Melissa L Goodhead
role: STUDY_CHAIR
References: