Advancing Treatments for Major Depressive Disorder

Access innovative major depressive disorder treatments while advancing medical research by participating in our new clinical trial evaluating a potential new treatment option.  

Those who qualify and choose to participate will be compensated for 9 in-clinic visits and 7 telephone visits over approximately 14 weeks.

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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.

Why Should I Participate?

Those who qualify and choose to participate could receive: 

Access to the investigational major depressive disorder treatment at no cost

Access to our top-tier team of board-certified physicians at no cost 

Compensation for 9 

in-clinic visits and 7 telephone visits over approximately

14 weeks

Study Criteria 

To qualify to participate you must: 

  • Be aged 18-64 years old
  • Have a diagnosis of major depressive disorder (MDD)
  • Have anxiety and insomnia
  • Additional criteria applies
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Frequently asked questions

What is a research study or clinical trial?

A research study or clinical trial is the process a potential new drug, device, procedure, or process goes through to prove that it is safe, tolerable and effective for the condition it is being studied for. Research studies are the only way to advance medicine for future generations. 

What is Informed Consent?

Every participant in every research study must go through the informed consent process. During this, the trial doctor and research team go over what will happen in the study, what treatments you might get, how long the trial is expected to last, what happens during visits, the potential risks and benefits, and many other important facts about the study. Participants may withdraw their consent and discontinue the study at any time for any reason. 

What is a Placebo?

A placebo looks like a treatment but does not have any active medicine in it. Researchers use placebos to help make sure any changes in the participants’ health are actually caused by the study treatment. You do not get to choose if you get the study treatment or the placebo, and you may not know if you get the placebo until after the study. Not all research studies use a placebo. 

Why is Diversity Important?

If studies do not include diverse participants, we cannot know if treatments work for everyone who needs them. Studies only tell researchers how something works for the participants of that study, and they may not work the same in people of different races, ethnicities, ages, or sexes.

How am I Protected?

All research studies must follow federal laws and ethical guidelines, including HIPAA. Studies must also be approved by an expert group called an institutional review board (IRB) that helps make sure the trial is fair and as safe as possible, and that any risks to the participants are worth the potential benefits.