A Randomized, Placebo-Controlled, Crossover Study of Atomoxetine in the Prevention of Vasovagal Syncope

What this Trial Is About

Vasovagal syncope (VVS) affects up to half of people and causes repeated fainting episodes that significantly reduce quality of life. Although some treatments exist, many patients cannot use them due to conditions like hypertension or heart failure. Researchers are studying atomoxetine, a medication approved for attention deficit disorder that acts as a norepinephrine transport inhibitor, to see if it can prevent syncope in adults with recurrent VVS. This trial aims to test atomoxetine's ability to reduce fainting episodes and improve quality of life in these patients. The trial is a randomized, double-blind, placebo-controlled, crossover study where participants will receive atomoxetine 40 mg twice daily or a matching placebo. Each treatment period lasts six months, separated by a one-week washout. Dosing starts at 40 mg once daily for 3 to 7 days before increasing to twice daily. Researchers will compare the frequency of syncope episodes between the atomoxetine and placebo periods and assess effects on anxiety, quality of life, injury, and cost-effectiveness. Participants will be monitored over a 12-month period with assessments every 3 to 6 months. These include questionnaires measuring anxiety, depression, quality of life, and medical utilization. Saliva samples will be collected to study genetic factors influencing treatment response. The primary outcome is the proportion of patients experiencing at least one syncope recurrence during each treatment phase. The study also includes safety monitoring and evaluates the broader impact of atomoxetine on patients' well-being.

Study of Atomoxetine in the Prevention of Vasovagal Syncope