Back to resultsPhase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Selegiline Transdermal System
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Mental Health, Adolescents, Major Depressive Disorder, Depression, Adolescent Depression, Pediatric Depression
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.
Sites / Locations
- Dr. Nelson Handal
- Dr. Mohammed Bari
- Dr. Michael McManus
- Dr. Elias Sarkis
- Dr. Scott Segal
- Dr. Mary Stedman
- Dr. Irving Kolin
- Dr. Rory Murphy
- Dr. Andrew Sediloo
- Dr. Bruce Waslick
- Dr. Christopher Kratochvil
- Dr. Ann Childress
- Dr. Melissa DelBello
- Dr. Leland Dennis
- Dr. David Brown
- Dr. Alain Katic
- Dr. Graham Emslie
- Dr. Mary Shemo
- Dr. John Gilliam
- Dr. Arifulla Khan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EMSAM
Placebo
Arm Description
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Placebo Selegiline Transdermal System 6, 9 or 12
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
CGI-S - Week 12 (mITT w/LOCF Population)
A summary of the Clinical Global Impression of Severity (CGI-S) at baseline and Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-s is the clinician's assessment of severity of illness (depression). Scores range from 1(minimum) to 7(maximum). A lower score indicates lower illness severity, a higher score indicates higher levels of illness severity.
CGI-C - Week 12 (mITT w/LOCF Population)
A summary of the Clinicians Global Impression of Change (CGI-C) Score at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-c assesses the overall change in the severity of illness (depression). The clinician rates the subject's change based on a bipolar scale from 1(minimum; "Very much improved") to 7(maximum; "Very much worse"). A lower score indicates lower levels of depression as compared to baseline, a higher score indicates higher levels of depression as compared to baseline. A score of 4 ("Unchanged") indicates no change in illness compared to baseline. The scale is not calculated as a statistical change score; the clinician rates their impression of change overall.
CGI-C Percent Responders (mITT w/LOCF Population)
A summary of the CGI-C percent responders at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. CGI-C responders were defined as a score of 1 or 2 at the end of the study. A non-responder was defined as a score of ≥3 at end of study. Maximum score is 100%.
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)
A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), 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 (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation.
CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)
A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), 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.
Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column.
CDRS-R (Best Description)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.
CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)
A summary of the secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Child), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC).
CDRS-R (Child) 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.
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)
A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC).
CDRS-R (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation.
CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)
A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with observed cases (w/OC).
Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom area. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column.
CDRS-R (Best Description) 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.
Physical Examination (Screening vs. EOS)
Number of physical examination findings that were normal at screening, but abnormal at end of study are presented. Four subjects receiving placebo and four subjects receiving EMSAM had abnormal findings on physical examination at the end of study that were normal at screening.
Urinalysis (Change From Baseline)
A summary of a secondary safety outcome measure, Urinalysis (Change from Baseline), by treatment assigned, is shown for the safety population. Mean changes from baseline are provided for PH and specific gravity.
Vital Signs-Heart Rate (Change From Baseline)
Summary mean change in heart rate measured in beats per minute (beats/min or BPM) (supine, standing, and orthostatic change)results for all subjects are presented.
Vital Signs-Blood Pressure (Change From Baseline)
Summary mean change in blood pressure (systolic/diastolic) measured in millimeters of mercury (mmHg) (supine, standing, and orthostatic change)results for all subjects are presented.
12 Lead ECG (Change From Baseline)
A summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline) measured in milliseconds (msec), by treatment assigned, is shown for the safety population. Mean change from Baseline in PR interval, QRS duration, QT interval, and QTc (Bazett and Fridericia corrections) interval are presented.
12 Lead ECG (Change From Baseline)Ventricular Heart Rate
A summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline)Ventricular Heart Rate measured in beats per minute(beats/min or BPM), by treatment assigned, is shown for the safety population. Mean change from baseline is presented.
Hematology - White Blood Cell (WBC) (Change From Baseline)
A summary of a secondary safety outcome measure, Hematology (Change from Baseline), by treatment assigned, is shown for the safety population. Mean change from Baseline in ABS BASOPHILS (X10^9/L), ABS EOSINOPHILS (X10^9/L), ABS LYMPHOCYTES (X10^9/L), ABS MONOCYTES (X10^9/L), and ABS NEUTROPHILS (X10^9/L) are presented.
Hematology - Hematocrit (Change From Baseline)
A summary of a secondary safety outcome measure, Hematology - Hematocrit(HCT)(Change from Baseline), by treatment assigned, is shown for the safety population.
Hematology - Hemoglobin (Change From Baseline)
A summary of a secondary safety outcome measure, Hematology - Hemoglobin(HGB)(Change from Baseline), by treatment assigned, is shown for the safety population.
Hematology - Red Blood Cell (Change From Baseline)
A summary of a secondary safety outcome measure, Hematology - Red Blood Cell (RBC)(Change from Baseline), by treatment assigned, is shown for the safety population.
Full Information
NCT ID
NCT00531947
First Posted
September 18, 2007
Last Updated
December 12, 2013
Sponsor
Somerset Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00531947
Brief Title
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
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Somerset Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Mental Health, Adolescents, Major Depressive Disorder, Depression, Adolescent Depression, Pediatric Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
308 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMSAM
Arm Type
Experimental
Arm Description
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Selegiline Transdermal System 6, 9 or 12
Intervention Type
Drug
Intervention Name(s)
Selegiline Transdermal System
Other Intervention Name(s)
EMSAM
Intervention Description
EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching Placebo Transdermal System
Intervention Description
Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Primary Outcome Measure Information:
Title
CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12
Description
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.
Time Frame
baseline and 12 Weeks
Secondary Outcome Measure Information:
Title
CGI-S - Week 12 (mITT w/LOCF Population)
Description
A summary of the Clinical Global Impression of Severity (CGI-S) at baseline and Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-s is the clinician's assessment of severity of illness (depression). Scores range from 1(minimum) to 7(maximum). A lower score indicates lower illness severity, a higher score indicates higher levels of illness severity.
Time Frame
Baseline and 12 Weeks
Title
CGI-C - Week 12 (mITT w/LOCF Population)
Description
A summary of the Clinicians Global Impression of Change (CGI-C) Score at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-c assesses the overall change in the severity of illness (depression). The clinician rates the subject's change based on a bipolar scale from 1(minimum; "Very much improved") to 7(maximum; "Very much worse"). A lower score indicates lower levels of depression as compared to baseline, a higher score indicates higher levels of depression as compared to baseline. A score of 4 ("Unchanged") indicates no change in illness compared to baseline. The scale is not calculated as a statistical change score; the clinician rates their impression of change overall.
Time Frame
12 Weeks
Title
CGI-C Percent Responders (mITT w/LOCF Population)
Description
A summary of the CGI-C percent responders at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. CGI-C responders were defined as a score of 1 or 2 at the end of the study. A non-responder was defined as a score of ≥3 at end of study. Maximum score is 100%.
Time Frame
12 Weeks
Title
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)
Description
A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), 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 (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation.
Time Frame
Baseline and 12 Weeks
Title
CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)
Description
A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), 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.
Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column.
CDRS-R (Best Description)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.
Time Frame
12 Weeks
Title
CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)
Description
A summary of the secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Child), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC).
CDRS-R (Child) 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.
Time Frame
12 Weeks
Title
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)
Description
A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC).
CDRS-R (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation.
Time Frame
12 Weeks
Title
CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)
Description
A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with observed cases (w/OC).
Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom area. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column.
CDRS-R (Best Description) 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.
Time Frame
12 Weeks
Title
Physical Examination (Screening vs. EOS)
Description
Number of physical examination findings that were normal at screening, but abnormal at end of study are presented. Four subjects receiving placebo and four subjects receiving EMSAM had abnormal findings on physical examination at the end of study that were normal at screening.
Time Frame
12 Weeks
Title
Urinalysis (Change From Baseline)
Description
A summary of a secondary safety outcome measure, Urinalysis (Change from Baseline), by treatment assigned, is shown for the safety population. Mean changes from baseline are provided for PH and specific gravity.
Time Frame
12 Weeks
Title
Vital Signs-Heart Rate (Change From Baseline)
Description
Summary mean change in heart rate measured in beats per minute (beats/min or BPM) (supine, standing, and orthostatic change)results for all subjects are presented.
Time Frame
12 Weeks
Title
Vital Signs-Blood Pressure (Change From Baseline)
Description
Summary mean change in blood pressure (systolic/diastolic) measured in millimeters of mercury (mmHg) (supine, standing, and orthostatic change)results for all subjects are presented.
Time Frame
12 Weeks
Title
12 Lead ECG (Change From Baseline)
Description
A summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline) measured in milliseconds (msec), by treatment assigned, is shown for the safety population. Mean change from Baseline in PR interval, QRS duration, QT interval, and QTc (Bazett and Fridericia corrections) interval are presented.
Time Frame
12 Weeks
Title
12 Lead ECG (Change From Baseline)Ventricular Heart Rate
Description
A summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline)Ventricular Heart Rate measured in beats per minute(beats/min or BPM), by treatment assigned, is shown for the safety population. Mean change from baseline is presented.
Time Frame
12 Weeks
Title
Hematology - White Blood Cell (WBC) (Change From Baseline)
Description
A summary of a secondary safety outcome measure, Hematology (Change from Baseline), by treatment assigned, is shown for the safety population. Mean change from Baseline in ABS BASOPHILS (X10^9/L), ABS EOSINOPHILS (X10^9/L), ABS LYMPHOCYTES (X10^9/L), ABS MONOCYTES (X10^9/L), and ABS NEUTROPHILS (X10^9/L) are presented.
Time Frame
12 Weeks
Title
Hematology - Hematocrit (Change From Baseline)
Description
A summary of a secondary safety outcome measure, Hematology - Hematocrit(HCT)(Change from Baseline), by treatment assigned, is shown for the safety population.
Time Frame
12 Weeks
Title
Hematology - Hemoglobin (Change From Baseline)
Description
A summary of a secondary safety outcome measure, Hematology - Hemoglobin(HGB)(Change from Baseline), by treatment assigned, is shown for the safety population.
Time Frame
12 Weeks
Title
Hematology - Red Blood Cell (Change From Baseline)
Description
A summary of a secondary safety outcome measure, Hematology - Red Blood Cell (RBC)(Change from Baseline), by treatment assigned, is shown for the safety population.
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hochadel, Pharm.D.
Organizational Affiliation
Cognitive Research Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Melissa L Goodhead
Organizational Affiliation
Somerset Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Nelson Handal
City
Dothan
State/Province
Alabama
Country
United States
Facility Name
Dr. Mohammed Bari
City
National City
State/Province
California
Country
United States
Facility Name
Dr. Michael McManus
City
SanDiego
State/Province
California
Country
United States
Facility Name
Dr. Elias Sarkis
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Dr. Scott Segal
City
North Miami
State/Province
Florida
Country
United States
Facility Name
Dr. Mary Stedman
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Dr. Irving Kolin
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Dr. Rory Murphy
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Dr. Andrew Sediloo
City
Owensboro
State/Province
Kentucky
Country
United States
Facility Name
Dr. Bruce Waslick
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Dr. Christopher Kratochvil
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Dr. Ann Childress
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Dr. Melissa DelBello
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Dr. Leland Dennis
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Dr. David Brown
City
Austin
State/Province
Texas
Country
United States
Facility Name
Dr. Alain Katic
City
Bellaire
State/Province
Texas
Country
United States
Facility Name
Dr. Graham Emslie
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Dr. Mary Shemo
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Dr. John Gilliam
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Dr. Arifulla Khan
City
Bellevue
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
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