NCT04476446

Who might be able to join this trial:

• You have treatment-resistant depression (depression that has not improved with other treatments) and there are no other available treatment options, including no suitable clinical trials nearby or that you qualify for
• You have been diagnosed with major depressive depression by a psychiatrist, either as a single long-lasting episode (lasting at least 2 years) or as recurring episodes, without any psychotic features
• You have tried at least 2 different antidepressant medications at proper doses for a proper length of time in your current episode of depression, and they did not work
• You have also tried at least one combination or add-on medication strategy that did not work, and you have either tried electroconvulsive therapy (ECT, a form of brain stimulation treatment), or have a medical reason you cannot have it, or do not have access to it, or have chosen not to have it
• You have already explored other clinical trials, early access programs, or special patient programs available in your area
• Your depression is considered moderate to severe by your doctor
• You are in generally stable physical health, based on a physical exam, medical history, blood pressure, and heart tracing (ECG) done before starting treatment
• Your blood test results (including blood counts, general chemistry, liver, and thyroid tests) are stable before starting
• You are comfortable giving yourself a nasal spray medication and can follow the instructions for how to use it
• If you are a woman who could become pregnant, you must use a highly effective form of birth control and have a negative pregnancy test before and during the program; if you are a man, you must agree to use a barrier method of contraception (such as a condom)
• You are willing and able to follow all the rules and requirements of the program
• You are willing to sign a consent form showing you understand and agree to take part

Who may not be able to join:

• Your depression did not improve when you previously tried esketamine nasal spray or ketamine during your current episode of depression
• You have been diagnosed with a psychotic disorder, depression with psychosis, bipolar disorder, or a significant intellectual disability
• You currently have thoughts of harming or killing others, or you have had thoughts of suicide with some intention to act on them in the past 6 months
• You have had a moderate or severe problem with alcohol or drug misuse (other than nicotine or caffeine) in the past 6 months; or you have ever had a misuse disorder related to ketamine, PCP, LSD, or MDMA (ecstasy) at any point in your life
• You currently have active, uncontrolled seizures (note: simple childhood fever-related seizures that caused no lasting problems are not a barrier); if you have a history of seizures, you may still be considered as long as your seizures are well-controlled and you have not had one in the past 6 months (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.