Evaluate the effect of age on the PK of two different doses of EMSAM.
Minimum age: 18 Years.
Maximum age: N/A.
1. Male or Female, 18 to 45years of age (inclusive) and 65 years of age or older.
2. Non-obese as defined by being within 15% of desirable body weight for frame size
3. In general good health as ascertained by physical examination (PE) including
measurement of supine and standing vital signs, medical history, clinical laboratory
studies, and 12-lead electrocardiogram (ECG).
4. Females must have a negative serum pregnancy test during screening confirmed by a
negative urine pregnancy screen at the baseline visit. Women of childbearing
potential must agree to continuously use a medically acceptable method of birth
control during the course of the study. Acceptable birth control methods are hormonal
contraceptives, intrauterine devices or double barrier method (a combination of condom
plus contraceptive foam). Postmenopausal females will be eligible to participate if
their last normal menses was at least one (1) year prior to study entry.
5. Able and willing to provide informed consent.
6. Able and willing to follow a modified diet.
7. Able and willing to follow the requirements of the study; willing to wear a patch, no
swimming, no excessive exercise, etc.
1. Presence of significant acute or chronic medical disorder that might complicate or
interfere with MAO inhibitor therapy, such as:
1. Any cardiovascular or cardiac condition requiring drug treatment. Upon review
with Sponsor, subjects with well controlled hypertension or hyperlipidemia will
2. History of symptomatic orthostatic hypotension, or in the investigator's best
clinicaljudgment a clinically significant postural decrease in systolic blood
pressure at screening or baseline.
3. Type I diabetes mellitus, or poorly controlled Type II diabetes mellitus.
4. Malignancy and/or chemotherapy within 1 year prior to screening, other than basal
cell carcinoma. Malignancies more than 1 year may not preclude participation and
will be reviewed on a case-by-case basis by the Somerset Pharmaceuticals, Inc.,
5. Any skin condition (e. g., eczema, psoriasis, dyshydrosis) that might interfere
with application and adherence of the STS.
6. Known or suspected hypersensitivity to selegiline or other MAO inhibitors.
7. Any significant immunological, pulmonary, hematologic, endocrine and/or metabolic
disease or disorder or severe or acute medical illness, that is, metastatic
cancer, brain tumors, decompensated cardiac, hepatic or renal failure.
8. Neurological disorders including delirium, history of head trauma, movement
disorders, dementia, multiple sclerosis, stroke, within the past 6 months
preceding the study.
2. Any central nervous system disorder including Alzheimer's disease, Parkinson's
disease, epilepsy, or cerebrovascular disease.
3. Any psychiatric disorders (except personality disorders).
4. Any mood disorder including MDD which is current or relapsed over the past three
6. Any conditions that may cause depression including endocrinopathies other than
diabetes, lymphoma, pancreatic cancer.
7. 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.
8. 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:
1. All contraindicated medications (see Section 7. 1.4. 3)
2. Psychotropic medication, including centrally active anticholinergics,
anticonvulsants, antiparkinsonian agents, fluoxetine (5 weeks), MAOIs (2 weeks),
antipsychotics (oral - 60 days; intramuscular - 10 weeks), anxiolytics,
vasodilators (exception: Viagra is permitted), cerebral enhancers
(acetylcholinesterase inhibitors), psychostimulants, lithium carbonate,
nootropics, reserpine, methyldopa (within 30 days), ergot preparations.
3. Sympathomimetic drugs, e. g., amphetamines, methylphenidate, dopamine,
epinephrine, norepinephrine, over-the-counter (OTC) and prescription nasal
decongestants (with the exception of nasal steroids), oral or inhaled
sympathomimetic bronchodilators (e. g., albuterol [Proventil], Serevent) and
4. Any serotonergic drug including sumatriptan succinate (Imitrex), zolmitriptan
(Zomig), cyproheptadine (Periactin), methysergide (Sansert) or other agonists
or antagonists of serotonin receptors.
5. Meperidine (Demerol), or other opioids.
6. R(-)tryptophan, metoclopramide.
7. St. John's wort / hypericum within two (2) weeks and other herbal supplements
8. Dietary supplements containing tyramine and/or ephedrine.
9. Presence of an Axis-II disorder that makes it unlikely that the subject will be
10. Presence or history of bipolar disorder or psychotic disorder.
11. Serious risk of suicide.
12. History of substance abuse, including alcohol abuse as defined by DSM-IV criteria,
within the past 12 months.
13. Current use of tobacco products.