Access innovative potential treatment for bipolar depression while advancing medical research by participating in our new clinical trial evaluating a potential new treatment option.
Those who qualify and choose to participate may be compensated for 8 visits over approximately 18 weeks.
This research study is designed for adults ages 18 to 74 who have been diagnosed with bipolar I or II disorder and are currently experiencing a moderate-to-severe depressive episode. The study is testing an investigational drug called azetukalner to see if it can help reduce the symptoms of bipolar depression.
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 azetukalner 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 azetukalner.
The study will consist of a screening period, a treatment period, and a follow up period over approximately 18 weeks and will require 8 in-clinic visits. If you qualify and choose to participate you could be compensated 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 depression.
Those who qualify and choose to participate could receive:
Access to the investigational
bipolar depression treatment
at no cost
Access to our top-tier team of board-certified physicians at no cost
Compensation for 8 visits over
approximately 18 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.
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.