Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression

Eligibility Criteria

• 1. Inpatient at a psychiatric unit at MGH
• 2. Male and female, 18-70 years of age
• 3. Diagnosis of Major Depressive Disorder, single or recurrent, based on DSM-5 criteria, and currently experiencing a major depressive episode (MDE) at least eight weeks in duration, prior to screening
• 4. Current suicidal ideation
• 5. In good general health, as ascertained by medical history, physical examination, clinical laboratory evaluations, and/or ECG
• 6. A status of non-childbearing potential or use of an acceptable form of birth control
• 7. Access to a mobile phone or computer with internet connection
• 8. Ability to read, understand, and provide written and dated informed consent prior to screening
• 9. Has a treating psychiatrist, either prior to admission or at discharge from the inpatient unit
• 1. Any history of previous treatment with IV ketamine
• 2. Pregnant or breastfeeding
• 3. A status of childbearing potential and is not willing to use birth control during the study
• 4. Unstable medical illness
• 5. Current diagnosis of a moderate to severe substance use disorder, within the last six months prior to screening based on DSM-5 criteria
• 6. History of bipolar disorder, or any psychotic symptoms in the current or previous depressive episodes
• 7. An Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within six months prior to screening (i.e., eating disorder, OCD, PTSD)
• 8. Currently receiving ECT treatment
• 9. Currently receiving frequent or high dose benzodiazepines, opiates, barbiturates, or other CNS depressant medications
• 10. Has dementia, delirium, amnestic, or any other primary cognitive disorder
• 11. Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results
• 12. Inability to consent to or comply with the study procedures.
• 13. Other medical issues that might affect safety, study participation, or confound interpretation of study results
• 14. Inability to comply with study safety procedures, including having reliable escorts to and from visits