McLean Hospital; Antidepressant Patch Could Become Standard Treatment for Depression.

Business Editors/Health/Medical Writers

BELMONT, Mass.--(BUSINESS WIRE)--Nov. 1, 2002

A new transdermal patch provides an effective antidepressant drug with an excellent side-effect profile, according to a study published in November's American Journal of Psychiatry. The drug is from a family of medications that are scarcely used, despite their effectiveness, because of occasionally serious side effects, and the patch may be an important step in restoring these powerful antidepressants to general use.

Research conducted at six national centers, including McLean Hospital, demonstrated that 42 percent of patients treated with the new antidepressant patch recovered after six weeks, and senior author Alexander Bodkin, MD, of McLean Hospital's Clinical Psychopharmacology Research Program, said many subjects on the patch showed remarkable improvement much sooner.

The drug, called selegiline, is a monoamine oxidase (MAO) inhibitor. MAO normally works in both the digestive system and the brain. In the digestive system, it detoxifies tyramine, a harmful by-product of the fermentation of protein, which is typically found in aged foods, such as cheese, soy sauce and beverages, such as wine. Taking an MAO inhibitor antidepressant in pill form can block this effect in the digestive system, allowing the tyramine to reach the blood stream. In some instances, this causes blood pressure to rise enough to potentially cause a hypertensive crisis, which can be extremely serious.

However, in the brain, MAO disposes of some neurotransmitters. Researchers believe that by blocking this function, MAO inhibitors give the depressed person a better supply of neurotransmitters to relieve symptoms, since there appears to be a shortage of certain neurotransmitters that underlies depression.

"So now we have a way of getting an MAO inhibitor antidepressant to the brain without interfering with the MAO in the digestive system," said Bodkin.

This is particularly important since MAO inhibitors are often more effective in individuals who get inadequate relief from other antidepressant medications. Currently only one percent of all prescribed antidepressants are MAO inhibitor drugs.

"Close to 20 percent of treated patients with depression do not do as well as they could. With selegiline in patch form, there will be a significant number of people who can get much better," said Bodkin.

This study of 177 patients with major depressive disorder also revealed a 94-percent compliance rate for those on the active patch. Bodkin says this is striking since compliance rates are generally much lower with traditional pill form antidepressants. For many reasons, depressed patients frequently miss their medications, and the high rate of adherence to treatment observed here might reflect an important therapeutic advantage of the transdermal route of administration.

Researchers discovered one prominent side effect. In 32 of the patients (36 percent), some form of an application site reaction, such as redness or irritation, occurred with the selegiline patch, but only three of the subjects dropped out of the study due to the reaction. However, compared to other antidepressants (whose side effects include weight gain, sleep problems and decreased sexual desire) this is a marked improvement, said the authors. They believe given FDA approval, and time for clinicians to become comfortable with the idea of a method of delivering a MAO inhibitor antidepressant with an excellent side-effect profile, the selegiline patch could become the first line of treatment for depression.

"More studies are needed to conclusively prove it, but it appears we may be getting close to a much needed treatment alternative: An easy-to-use MAO inhibitor antidepressant with an excellent side-effect profile," said Bodkin.

The research was supported by, and the selegiline patch is being developed by, Somerset Pharmaceuticals, Inc. of Tampa, Florida.

McLean Hospital maintains the largest research program of any private, U.S. psychiatric hospital. It is the largest psychiatric teaching facility of Harvard Medical School, an affiliate of Massachusetts General Hospital and a member of Partners HealthCare.