The Cleo Study is evaluating an oral study medication, an oral esketamine tablet, to see if it may reduce symptoms of depression. If you have tried at least 2 medications for your depression and have not seen sufficient improvement, the Cleo Study may be an option. If you qualify for the study, you would continue taking your current depression medication along with the oral study medication.
You may be able to participate in the Cleo Study if you:*
*Other criteria will apply.
If you qualify and enroll, you will receive:
Your participation is voluntary, and you may choose to withdraw from the study at any time.
Major Depressive Disorder (MDD), also referred to as clinical depression, is a medical condition where feelings of sadness or other symptoms last longer than 2 weeks at a time and interfere with your daily life.1
People living with depression often experience:
Up to one-third of individuals diagnosed with depression do not adequately respond to existing treatments for their symptoms, so there is a need for new therapies.2 This inadequate response can be referred to as treatment-resistant depression, generally defined as having tried at least 2 medications for depression with little or no improvement in symptoms.
The Cleo Study is designed to find out how effective the study therapy is at improving depressive symptoms for people who have tried other treatments for major depressive disorder without sufficient improvement. It will enroll about 120 people suffering from major depressive disorder.
If you are eligible and decide to join the Cleo Study, your participation will last 6 to 10 weeks and include:
Deciding to participate in a clinical research study is an important and personal decision. Before you agree to participate, the study team will review all aspects of the clinical research study with you. You will be given a document called an Informed Consent Form that provides, in writing, the clinical research study’s purpose, assessments, procedures, benefits, risks, and precautions. You will have the opportunity to ask questions and are encouraged to speak with your own physician to decide if taking part is right for you.
Yes, there is a 1 in 2 (50%) chance you will receive the oral study medication and a 1 in 2 (50%) chance you will receive placebo. A placebo looks like the investigational medication but is an inactive substance. It is sometimes used in clinical research studies to evaluate the safety and effectiveness of the treatment. Regardless of whether you receive the oral study medication or placebo, you will continue taking your current medication for depression.
Yes, your participation in any clinical research study is completely voluntary. If you decide to participate in a clinical research study, you are always free to withdraw at any time for any reason without any penalty or effect on your future medical care.
Your doctor does not have to give you permission to participate. However, you are encouraged to talk to your doctor about participating in the study. With your permission, the study doctor will keep your regular doctor updated about your condition during the study. You will also remain on your current depression medication prescribed by your regular doctor.
If you have questions or want more information, please contact:
Yes, the information you provide will not be shared with anyone who is not directly associated with this clinical research study without your permission (except as required by law) or as set forth in the informed consent.
The study staff can give you more information about compensation and transportation.
About 120 people will participate in the Cleo Study.
The study sponsor is Clexio Biosciences Ltd.
Clinical research studies help scientists and doctors explore whether a medical strategy, medication, or device is safe and effective for people. Before a strategy, medication, or device can be prescribed to treat a certain condition, it must go through several phases of clinical research.
There is no guarantee the oral study medication will improve your condition, but what we learn from this study may help provide future treatment options for people who have tried at least 2 medications for depression with little or no improvement in their symptoms.
To help ensure that a clinical research study is ethical, and that participants’ rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review study protocols.