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 who are able to give informed consent to participate in the study
• People who have been diagnosed with major depressive disorder (without psychotic features) based on a structured clinical interview
• People whose depression symptom score on a standard questionnaire (called the PHQ-9) is 15 or higher at the screening appointment
• People whose depression has not responded to at least two previous treatments during their current depressive episode — this can include antidepressant medications taken at an adequate dose for at least 8 weeks, a course of transcranial magnetic stimulation (TMS), or a series of at least 6 electroconvulsive therapy (ECT) sessions
• People who are able to pass a short comprehension test about ketamine's effects and the goals of the trial

Who may not be able to join:

• People who are not able to communicate in English
• People who are not able to give consent themselves and do not have a legal guardian
• People with a body mass index (a measure of body weight relative to height) above 40
• People whose primary diagnosis is a personality disorder
• People who have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or who currently have psychotic symptoms
• People who currently have active post-traumatic stress disorder symptoms, based on a clinical assessment
• People who are currently prescribed more than a certain daily dose of sedative medications called benzodiazepines, or who take any benzodiazepine in the morning at the time of assessment (confirm with trial site for exact dose details)
• People taking certain medications that affect brain chemicals called glutamate or GABA — including Riluzole, Carbamazepine, zaleplon, zolpidem, zopiclone, Valproate, Gabapentin, Pregabalin, tiagabine, and vigabatrin — within two weeks before or 24 hours after receiving the study drug
• People taking a class of antidepressants called MAOIs (monoamine oxidase inhibitors) within two weeks before receiving the study drug
• People taking opioid-blocking medications (such as naltrexone, naloxone, nalmefene, methylnaltrexone, or a buprenorphine/naloxone combination) within two weeks before or 24 hours after receiving the study drug
• People taking the medications carbamazepine or modafinil within two weeks before or 24 hours after receiving the study drug
• People currently receiving TMS, vagal nerve stimulation, or deep brain stimulation as a treatment for depression
• People who have had ECT treatment within the past 6 months
• People with an active or unstable physical health condition that the study psychiatrist considers too medically risky for participation
• People with a history of bleeding in the brain
• People with an arteriovenous malformation (an abnormal tangle of blood vessels) or a history of a brain aneurysm
• People who have used methamphetamine, cocaine, or cannabis, or misused stimulant drugs within the past 12 months
• People with a current substance use disorder, except for nicotine or caffeine — though people who have been in full remission for more than one year may still be considered (confirm with trial site)
• People with a history of traumatic brain injury that caused loss of consciousness and bleeding in the brain
• People with a history of tonic-clonic (grand mal) seizures
• People with a developmental delay, intellectual disability, or intellectual disorder
• People who have experienced delirium, encephalopathy, or a related condition within the past 12 months, either diagnosed by a clinician or self-reported
• People with a minor or major neurocognitive disorder (a condition affecting memory, thinking, or brain function)
• People who have received ketamine treatment for depression within the past 2 months
• People who have previously had a poor response to ketamine or experienced significant side effects from it, regardless of how it was given
• People with a history of an underactive thyroid (hypothyroidism), unless they have been on a stable thyroid medication dose and have had no symptoms for at least 3 months
• People with liver problems, a past liver transplant, or a diagnosis of liver cirrhosis (confirm with trial site for specific test value thresholds)
• People with poorly controlled gastroesophageal reflux disease (a condition where stomach acid frequently flows back into the throat)
• People who have been diagnosed with Complex Regional Pain Syndrome (a chronic pain condition)
• People who are pregnant or currently breastfeeding
• People with claustrophobia (fear of enclosed spaces) that would interfere with having an MRI scan
• People with any condition or factor that would make an MRI scan unsafe for them
• People with poorly controlled high blood pressure

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