Table 1.
CRITERION | METHOD OF ASCERTAINMENT | |
---|---|---|
| ||
Inclusion | 1. 18–65 years old | Interview |
2. DSM51 unipolar or bipolar (I, II, or Unspecified) major depressive episode | MINI2 diagnostic interview | |
3. Assessed by psychiatric ED staff as needing inpatient treatment due to suicide risk | ED clinical assessment | |
4. Subject agrees to voluntary inpatient admission | Interview | |
5. Beck Scale for Suicidal Ideation (SSI) score of 4 or higher | SSI scale | |
6. Subjects 60–65 years old must score 25 or higher on the Mini Mental Status Exam (MMSE) at screening | MMSE | |
Exclusion | 1. Co-occurring substance excluded if: acute intoxication or withdrawal; more than rare recreational use of opioids/ ketamine/PCP (e.g. >once in past year); needs specialized addiction treatment/detox and cannot be handled on study units; primary alcohol/substance disorder with secondary depression | Assessed case by case in collaboration with ED team based on labs, clinical assessment, and study screening |
2. Current psychosis or mania | Clinical and MINI2 assessments | |
3. Intellectual disability | Clinical assessment | |
4. Inadequate understanding of English and/or lack of capacity for informed consent. | Clinical assessment | |
5. Pregnancy or lactation | Urine or blood pregnancy test | |
6. Any medical contraindication to ketamine or midazolam; Total current dose of lorazepam or benzodiazepine equivalent greater than 3 mg daily is excluded. | Medical history | |
7. Unstable medical or neurological illness such as uncontrolled hypertension, significant cardiac arrhythmia, unstable cerebrovascular disease. Chronic, stable medical conditions such as controlled hypertension or diabetes are not excluded. | Medical history, labs, and ECG |
DSM5 = Diagnostic and Statistical Manual of Mental Disorders Fifth Edition.
MINI = Mini International Neuropsychiatric Interview.