Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
This study has been completed.
Sponsor:
Somerset Pharmaceuticals
Information provided by:
Somerset Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00531947
First received: September 18, 2007
Last updated: February 28, 2011
Last verified: February 2011
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mental Health Major Depressive Disorder |
Drug: Selegiline Trandermal System Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:
- Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for MDD without psychotic features, single or recurrent [ Time Frame: 24 Months ]
| Estimated Enrollment: | 300 |
| 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 |
|---|---|
|
Active
Approved Medication for Major Depresive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
|
Drug: Selegiline Trandermal System
EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Other Name: EMSAM
|
|
Placebo Comparator: B
Placebo Selegiline Transdermal System 6, 9 or 12
|
Drug: Placebo |
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 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 MDD. (Must have a 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
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: | Melissa Goodhead, B.Sc., RAC, Somerset Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00531947 History of Changes |
| Other Study ID Numbers: | S9303-P0605 |
| Study First Received: | September 18, 2007 |
| Last Updated: | February 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Somerset Pharmaceuticals:
|
Mental Health Adolescents Major Despressive Disorder |
Depression Adolescent Depression Pediatric Depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Selegiline Monoamine Oxidase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents Therapeutic Uses Antiparkinson Agents Anti-Dyskinesia Agents |
ClinicalTrials.gov processed this record on May 23, 2013