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Evaluate the effect of age on the PK of two different doses of EMSAM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | EMSAM 6mg |
|
| B | Active Comparator | EMSAM (Selegiline Transdermal System) 12mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMSAM (Selegiline Transdermal System) 6mg | Drug | STS 6mg/24hr |
| |
| EMSAM (Selegiline Transdermal System) 12mg |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Proportionality of PK parameters and EMSAM release characteristics. | 33 days |
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Inclusion Criteria:
Exclusion Criteria:
Presence of significant acute or chronic medical disorder that might complicate or interfere with MAO inhibitor therapy, such as:
Any central nervous system disorder including Alzheimer's disease, Parkinson's disease, epilepsy, or cerebrovascular disease.
Any psychiatric disorders (except personality disorders).
Any mood disorder including MDD which is current or relapsed over the past three years.
ADHD.
Any conditions that may cause depression including endocrinopathies other than diabetes, lymphoma, pancreatic cancer.
Any other illness or disorder that in the opinion of the Investigator would place the subject at significant risk or any inability to follow the requirements of the study regarding maintaining scheduled visits or patch applications.
Use of any medication listed below within five half-lives prior to baseline. A longer period of time may be specifically noted for certain medications as indicated:
Presence of an Axis-II disorder that makes it unlikely that the subject will be compliant.
Presence or history of bipolar disorder or psychotic disorder.
Serious risk of suicide.
History of substance abuse, including alcohol abuse as defined by DSM-IV criteria, within the past 12 months.
Current use of tobacco products.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Honolulu | Hawaii | United States |
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| ID | Term |
|---|---|
| D012642 | Selegiline |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Drug |
EMSAm 12mg/24Hr |
|