Atomoxetine for Fainting (Vasovagal Syncope)

(POST7 Trial)

This trial tests atomoxetine, a medication, to determine if it can prevent fainting spells in individuals with recurrent vasovagal syncope, a condition causing sudden drops in heart rate and blood pressure that lead to fainting. The goal is to find a simple treatment to reduce fainting incidents and improve the quality of life for those affected. Participants will receive either atomoxetine or a placebo (a harmless pill with no active drug) to compare results. Individuals who have fainted at least twice in the past year due to vasovagal syncope might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Yes, you will need to stop taking certain medications before participating in this trial. Specifically, you cannot be on β-blockers, bupropion, α1-adrenergic agonists or antagonists, tricyclic antidepressants, serotonin reuptake inhibitors, scopolamine, theophylline, or fludrocortisone.

Research shows that atomoxetine, a drug approved for treating attention deficit disorder, is being tested for its potential to help with vasovagal syncope, a type of fainting spell. In earlier studies, participants who took atomoxetine fainted less often than those who received a placebo. Specifically, one study found that fewer participants fainted during a tilt test after taking atomoxetine compared to a placebo (10 out of 29 with atomoxetine vs. 19 out of 27 with placebo).

Unlike the standard treatments for vasovagal syncope, which often include lifestyle changes and medications like beta-blockers or fludrocortisone, atomoxetine offers a unique approach. Atomoxetine is traditionally used for ADHD and works by increasing norepinephrine levels, which may help stabilize blood pressure and reduce fainting episodes. This new mechanism of action is what excites researchers, as it targets the condition from a different angle, potentially offering relief for those who don't respond well to existing therapies.

Research has shown that atomoxetine, a medication typically used for attention deficit disorder, might help reduce fainting episodes in people with vasovagal syncope. In this trial, participants will receive either atomoxetine or a placebo. One study found that fewer people fainted when taking atomoxetine compared to those taking a placebo. Specifically, only 10 out of 29 people fainted on atomoxetine, while 19 out of 27 fainted on the placebo. Another study found that 11 out of 12 people improved with atomoxetine, and 7 of them did not faint at all. These results suggest that atomoxetine may help prevent fainting by affecting a part of the body that controls reflexes related to fainting. This makes atomoxetine a possible treatment for those who often experience troublesome fainting spells.⁵⁶⁷⁸⁹