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 between 18 and 65 years old (either staying in hospital or attending as an outpatient).
• You are able and willing to sign a consent form before the trial begins (a legal guardian may co-sign if needed).
• If you are a woman who could become pregnant, you must use effective contraception during the trial and have a negative pregnancy test before starting.
• You have been diagnosed with major depressive disorder (without psychosis), confirmed using a standard psychiatric interview.
• Your current antidepressant treatment has not worked well enough, and a clinician has confirmed this — ideally you have been on a standard antidepressant at the right dose for at least 4 weeks.
• You and your doctor are planning to change your current medication (though other types of treatment changes are also considered).
• Your depression symptoms are at least moderate in severity, shown by a score of 20 or more on a standard depression rating scale.
• Your depression is affecting your daily functioning, shown by a score of 5 or higher on at least one area of a standard disability scale.

Who may not be able to join:

• You are currently pregnant or breastfeeding.
• You have previously been treated with (es)ketamine for depression.
• You are known to have had a bad reaction or intolerance to (es)ketamine or to all available standard treatment medications.
• You have any medical reasons (including abnormal blood tests, ECG, or physical exam results) that make (es)ketamine or all standard treatment options unsafe for you.
• You have taken part in another clinical trial involving an experimental drug or treatment within the last 30 days.
• You have another significant illness or condition that the trial doctor believes could put you at risk or affect the trial results.
• You are currently having serious thoughts of suicide with some intention or a specific plan, and a clinician has decided it would not be safe for you to participate (confirm with trial site).
• You currently have a severe drug or alcohol use disorder — mild or moderate alcohol or cannabis use disorder, and nicotine dependence, may still be allowed (confirm with trial site).
• You have been placed in a care or medical institution by a legal or government order.
• You have a close personal or professional relationship with the trial sponsor, investigator, or trial site.

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