Selegiline TDS for Healthy Adults

This trial tests a new skin patch for delivering Selegiline, a medication often used for mood disorders, to evaluate its adhesion and drug absorption compared to an existing patch called EMSAM®. Researchers assess the patch's safety and comfort. The trial targets healthy, non-smoking adults without skin conditions that could affect the patch's use, and participants must follow study instructions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research studies have shown that the selegiline transdermal system (TDS) is generally safe, meaning most people can use it without major issues. It causes fewer side effects related to sexual health. Studies on EMSAM, the brand name for selegiline TDS, have shown similar safety results. In trials, participants experienced few serious side effects, and the overall safety matched findings from past studies with healthy adults. This suggests that selegiline TDS is likely safe for most people, with only mild to moderate side effects expected.¹²³⁴⁵

Unlike the standard EMSAM® transdermal patch, which is already used to treat depression by delivering selegiline through the skin, the investigational Selegiline Transdermal Delivery System (TDS) may offer a new twist on this method. Researchers are excited about this treatment because it may provide more consistent drug delivery or improved absorption, which could enhance its effectiveness or reduce side effects. By exploring this new delivery system, scientists hope to refine how selegiline can be used to better manage symptoms with fewer complications.

Studies have shown that the Selegiline Transdermal Delivery System (TDS) effectively treats major depressive disorder (MDD). Specifically, EMSAM, a brand of Selegiline TDS, has proven to improve depression symptoms. In this trial, participants will receive either the Selegiline TDS or EMSAM on different arms to compare their effects. This system delivers medication through the skin, increasing its availability in the body compared to pills. It also avoids many food interactions that pills can cause. The medication reaches effective blood levels within 4 to 8 hours and remains stable, making the treatment both effective and generally well-tolerated by patients.¹²⁴⁵⁶