Phase 3 Depression and Anxiety Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years old or older
• You are willing to sign a consent form and take part in all parts of the study for its full duration
• You have been diagnosed with major depressive disorder that has not improved after trying at least two different antidepressant medications
• Your depression is rated as moderate or severe based on a standard scoring tool used at the start of the study
• A doctor has already decided that ketamine or esketamine would be a suitable treatment for you, regardless of this trial
• If you are a woman who could become pregnant, you must be using a very reliable form of birth control (with a failure rate of less than 1% per year when used correctly) during the study and for one week after your last dose — acceptable methods include hormonal contraception (pill, patch, or vaginal ring), an IUD, an intrauterine hormone-releasing system, permanent sterilisation (such as tubal ligation), a partner who has had a vasectomy with confirmed results or surgical removal of both testicles, or a condom or diaphragm or sponge used together with spermicide (note: a condom used alone is not considered reliable enough)
• If you are a woman who could become pregnant, you must agree not to donate eggs or freeze eggs for future fertility use during the study

Who may not be able to join:

• You have been diagnosed with bipolar disorder or a psychotic disorder such as schizophrenia or schizoaffective disorder
• You have had a substance use disorder (other than tobacco/nicotine) that is currently active or occurred within the past 12 months
• You are currently pregnant or breastfeeding
• You have had bleeding in the brain or a weakened blood vessel (such as an aneurysm) in the brain
• You have a known allergy or sensitivity to ketamine, esketamine, or any of their ingredients
• There is a known history of ketamine addiction in your immediate family
• You have previously had a problem with ketamine use yourself, or taking part in this study would mean you have had more than 8 exposures to ketamine in your lifetime (including past medical or recreational use); previous use of esketamine is also disqualifying
• You have high blood pressure that is not well controlled — specifically, a reading above 145/90 at your screening visit (a slightly higher reading of up to 150/95 may be allowed on treatment days to account for nervousness at appointments)
• You have a known heart or blood vessel condition that could make ketamine or esketamine risky for you, including certain growths or lesions in the brain, or an abnormal result on a heart tracing (ECG/EKG) that increases your risk
• You have any condition where a sudden rise in blood pressure would be seriously dangerous
• You have an arteriovenous malformation (an abnormal tangle of blood vessels in the brain or elsewhere) (confirm with trial site)
• You test positive for drugs on a urine screen at your screening visit, unless those substances were prescribed to you — a positive result for cannabis (THC) will only be disqualifying if your pattern of use suggests cannabis use disorder; however, using cannabis within 24 hours of a treatment session is not allowed
• You test positive for alcohol at your screening visit, or show obvious signs of being intoxicated
• You are unable to arrange for someone else to drive you home after each treatment session, or you are unwilling to avoid driving and operating machinery for the rest of the treatment day and through the following night

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