Help advance medical research in bipolar mania by taking part in a clinical trial evaluating an investigational treatment option.
Those who qualify and choose to participate may be compensated up to $3,600 for a 15-day inpatient period, followed by a 2-week follow up period with 3 outpatient visits.
This research study is designed for adults ages 18 to 65 who have been diagnosed with bipolar I and are experiencing acute exacerbation or relapse of mania requiring hospitalization and are currently being treated with a therapeutic dose of either lithium, valproate, or lamotrigine. The study is testing an investigational drug called KarXT to see if it can help reduce the symptoms of acute mania in those with bipolar I. The study drug has already been studied in multiple clinical studies, and it is approved in the US for treating schizophrenia in adults.
The study is randomized, double-blind, and placebo-controlled to ensure high-quality, unbiased results. If you qualify and choose to participate, there is a 50% chance you will receive the study treatment and a 50% chance you will receive a placebo. A placebo is an inactive material that looks like the study drug but does not contain any active ingredient. After the main treatment phase, you may have the opportunity to join an open-label extension study, where all participants receive the study drug.
The study will consist of a screening period, a treatment period, and a follow up period over approximately 9 weeks and will require a 15-day inpatient stay. If you qualify and choose to participate you could be compensated up to $3,600 for your study-related time. Throughout the study, your health and progress will be closely monitored by the study team. Your participation could help advance research and bring new hope to those living with bipolar mania.
Those who qualify and choose to participate could receive:
Access to the potential bipolar mania treatment at no cost
Access to our top-tier team of board-certified physicians at no cost
Compensation of up to $3,600 over approximately 9 weeks
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.
Each study has its own set of inclusion and exclusion criteria that a participant must meet before they are allowed to participate in a study. Patients from all backgrounds and walks of life are encouraged to participate.
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.
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.
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.
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.