About the Study
This research study is for adults ages 18 to 64 who have been diagnosed with major depressive disorder (MDD) and who are currently experiencing symptoms of depression, along with some anxiety and insomnia. The study is evaluating an investigational medication called zelquistinel (GATE-251) to find out if it can help reduce symptoms of MDD. Additional aims are to assess how safe the medication is compared to a placebo.
This study is randomized, double-blind, and placebo-controlled. This means that if you qualify and decide to participate, you will have a 50% chance of receiving zelquistinel and a 50% chance of receiving a placebo, which looks like the study drug but contains no active ingredient. These methods help to ensure the results are accurate and unbiased. Neither you nor the study doctor will know which study drug you will receive.
The study will include a screening period, a treatment period, and a follow-up period over about 14 weeks, with 9 in-clinic visits and 7 telephone visits required. If you qualify and participate, you could receive up to $2,725 for your study-related time. Throughout the study, your health and progress will be carefully monitored by a team of board-certified physicians. By participating, you may help advance research that could bring new options to people living with major depressive disorder.