Phase 2 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:

• People aged 18 to 55 years old.
• People who are able to understand the study well enough to agree to all required tests, sign a consent form, and score 90% or higher on a quiz about the study.
• People who have been diagnosed with major depressive disorder (a serious form of ongoing low mood and depression) — either a first episode or recurring episodes — without any features of psychosis, confirmed through a structured clinical interview.
• People who are currently experiencing a depressive episode that has lasted at least 2 weeks.
• People who have tried at least one standard antidepressant medication in the past and it did not work well enough.
• People whose depression symptoms score at a certain level of severity (a score of 20 or above on a standard depression rating scale) both at the start of the study and on the day of the ketamine infusion.

Who may not be able to join:

• People who do not have enough knowledge of their family's mental health or substance use history (for example, due to adoption).
• People who currently experience psychotic symptoms (such as hallucinations or delusions), or who have previously been diagnosed with a psychotic disorder such as schizophrenia, schizoaffective disorder, or bipolar disorder.
• People who currently have a diagnosis of substance use disorder (other than dependence on caffeine or nicotine).
• People who are pregnant, breastfeeding, or able to become pregnant and not using at least one accepted form of contraception.
• People with serious or unstable physical health conditions affecting organs such as the liver, kidneys, lungs, heart, or nervous system — for example, uncontrolled asthma, uncontrolled thyroid problems, or active cancer.
• People with any medical condition likely to affect brain structure or function (such as high blood pressure or diabetes), even if the condition is currently managed with medication.
• People with significantly abnormal results on routine laboratory (blood or urine) tests.
• People who have had one or more seizures without a clear explanation that has been fully resolved, or who have had a head injury causing loss of consciousness for more than 5 minutes or requiring a hospital stay.
• People who have been taking certain psychiatric medications (such as antidepressants, benzodiazepines, or antipsychotics) within at least two weeks before the treatment phase of the study.
• People who have taken the antidepressant fluoxetine within 5 weeks before the treatment phase of the study.
• People who have received device-based depression treatments — such as electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagal nerve stimulation (VNS) — within 4 weeks before the treatment phase.
• People who have ever had deep brain stimulation at any point in their life.
• People who are currently taking any other medications that are not permitted by the study.
• People who test positive for HIV.
• People who have metal implants in their body (such as a pacemaker or aneurysm clip), or who have other reasons they cannot have an MRI scan (such as claustrophobia or significant hearing loss).
• People for whom a routine brain MRI scan shows a significant abnormality in brain structure.
• People who, in the study doctor's judgment, are currently at serious risk of harming themselves or others, or who score 4 or higher on the suicidal thoughts portion of the depression rating scale.
• Current employees or staff of the NIMH (National Institute of Mental Health), or their close family members (confirm with trial site regarding relevance at other locations).
• People currently receiving a structured, evidence-based talking therapy for mood or anxiety disorders, such as cognitive-behavioural therapy (CBT) or interpersonal psychotherapy (IPT).
• The trial investigators may also exclude or remove any participant from the study based on their clinical judgement.

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