Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Somerset Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00531947
First received: September 18, 2007
Last updated: December 12, 2013
Last verified: December 2013
  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 (MDD).


Condition Intervention Phase
Major Depressive Disorder
Drug: Selegiline Transdermal System
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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:


Further study details as provided by Somerset Pharmaceuticals:

Primary Outcome Measures:
  • CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12 [ Time Frame: baseline and 12 Weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 308
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
Experimental: EMSAM
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Drug: Selegiline Transdermal System
EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Other Name: EMSAM
Placebo Comparator: Placebo
Placebo Selegiline Transdermal System 6, 9 or 12
Drug: Placebo
Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Other Name: Matching Placebo Transdermal System

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

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Somerset Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00531947     History of Changes
Other Study ID Numbers: S9303-P0605
Study First Received: September 18, 2007
Results First Received: December 27, 2012
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 22, 2014