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

December 12, 2013 updated by: Somerset Pharmaceuticals

A Phase IV, Double-Blind, Placebo-Controlled, Randomized, Flexible Dose Study of the Safety and Efficacy of EMSAM in Adolescents With Major Depression

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).

Study Overview

Status

Completed

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

Study Type

Interventional

Enrollment (Actual)

308

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMSAM
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Other Names:
  • EMSAM
Placebo Comparator: Placebo
Placebo Selegiline Transdermal System 6, 9 or 12
Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Other Names:
  • Matching Placebo Transdermal System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12
Time Frame: baseline and 12 Weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGI-S - Week 12 (mITT w/LOCF Population)
Time Frame: Baseline and 12 Weeks
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.
Baseline and 12 Weeks
CGI-C - Week 12 (mITT w/LOCF Population)
Time Frame: 12 Weeks
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.
12 Weeks
CGI-C Percent Responders (mITT w/LOCF Population)
Time Frame: 12 Weeks
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%.
12 Weeks
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)
Time Frame: Baseline and 12 Weeks

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.

Baseline and 12 Weeks
CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)
Time Frame: 12 Weeks

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.

12 Weeks
CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)
Time Frame: 12 Weeks

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.

12 Weeks
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)
Time Frame: 12 Weeks

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.

12 Weeks
CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)
Time Frame: 12 Weeks

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.

12 Weeks
Physical Examination (Screening vs. EOS)
Time Frame: 12 Weeks
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.
12 Weeks
Urinalysis (Change From Baseline)
Time Frame: 12 Weeks
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.
12 Weeks
Vital Signs-Heart Rate (Change From Baseline)
Time Frame: 12 Weeks
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.
12 Weeks
Vital Signs-Blood Pressure (Change From Baseline)
Time Frame: 12 Weeks
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 Weeks
12 Lead ECG (Change From Baseline)
Time Frame: 12 Weeks
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 Weeks
12 Lead ECG (Change From Baseline)Ventricular Heart Rate
Time Frame: 12 Weeks
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.
12 Weeks
Hematology - White Blood Cell (WBC) (Change From Baseline)
Time Frame: 12 Weeks
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.
12 Weeks
Hematology - Hematocrit (Change From Baseline)
Time Frame: 12 Weeks
A summary of a secondary safety outcome measure, Hematology - Hematocrit(HCT)(Change from Baseline), by treatment assigned, is shown for the safety population.
12 Weeks
Hematology - Hemoglobin (Change From Baseline)
Time Frame: 12 Weeks
A summary of a secondary safety outcome measure, Hematology - Hemoglobin(HGB)(Change from Baseline), by treatment assigned, is shown for the safety population.
12 Weeks
Hematology - Red Blood Cell (Change From Baseline)
Time Frame: 12 Weeks
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.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Thomas Hochadel, Pharm.D., Cognitive Research Corporation
  • Study Chair: Melissa L Goodhead, Somerset Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

September 18, 2007

First Submitted That Met QC Criteria

September 18, 2007

First Posted (Estimate)

September 19, 2007

Study Record Updates

Last Update Posted (Estimate)

January 15, 2014

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

December 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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