NCT02106325.

Study name	A randomized, double‐blinded controlled trial of an N‐Methyl D‐Aspartate antagonist as a rapidly‐acting antidepressant in depressed emergency department patients
Methods	Investigators will conduct a trial to evaluate the use of ketamine as an alternate treatment for people with major depressive disorder. This study plans to explore the potential that ketamine's rapid antidepressant action holds for improving outcomes in patients presenting to the Emergency Department with severe depression. Since this is a controlled trial we will use an IV of Ketamine or and equivalent volume of Diphenhydramine. Sixty participants will be randomly assigned to receive Ketamine (30 participants) or Benadryl (30 participants). Investigators will then compare measures of mood pre‐ and post‐infusion in the Emergency Department. to supplement self‐reported measures of depressive symptoms(e.g. mood), investigators will obtain objective measures of the biological aspects of Major Depressive Disorder. With the current evidence pertaining to our hypothesis, investigators hope to add to the growing scientific studies surrounding such a vulnerable population Allocation: randomised Endpoint classification: safety/efficacy study Intervention model: single group assignment Masking: double‐blind (participant, investigator, outcomes assessor) Primary purpose: treatment
Participants	Inclusion criteria Medically stable as determined by the medical physician Meets criteria for Major Depressive Disorder (MDD) based on a structured clinical Interview (MINI International Neuropsychiatric Interview) Reports symptoms of severe depression at the time of presentation, defined as a score of 24 or greater on the MADRS Patients for whom a psychiatric evaluation and disposition decision has been made by emergency psychiatry staff to admit to an inpatient psychiatric unit at Bellevue Hospital Center or NYU Tisch Hospital Each participant must have a level of understanding sufficient to sign an informed consent stating that the treatment being offered is not FDA approved for the treatment of depression and is being provided as an off‐label option Exclusion criteria Pregnancy Inability to read or understand English Current clinical signs of intoxication or delirium at time of study intervention Overdose, within previous 24 hours, of any agent which would impair ketamine metabolism Lifetime misuse/abuse of ketamine, phencyclidine (PCP), or related substances Lifetime history of psychotic spectrum illness First‐degree relative with history of psychotic illness Lifetime diagnosis of borderline personality disorder, or as confirmed by assessment using items #90‐104 of the SCID‐II (for DSM‐IV) Particpants with clinically significant abnormal findings as determined by medical history, physical examination, vital signs (blood pressure, heart rate, and respiration rate), O2 saturation measure, 12‐lead ECG, clinical laboratory tests (CBC, chemistry panel, thyroid function tests), urine drug screen, and urine pregnancy test (for females of childbearing potential only) Clinically unstable medical, surgical or neurological conditions at ED presentation History of stroke or intracranial hypertension History of glaucoma Particpants with one or more seizures without a clear and resolved etiology Current NMDA antagonist medications (e.g.. amantadine, rimantadine, lamotrigine, memantine, dextromethorphan) Known hypersensitivity to ketamine or amantadine Anti‐psychotic medications (Typicals or Atypicals), with the exception of low‐dose quetiapine (total daily dose of 100 mg or less) Actively trying to commit suicide, even in a hospital setting Current homicide risk Unable or unwilling to give informed consent according to HIC guidelines Unable or unwilling to provide 2 contact phone numbers or be followed up per study protocol. Previous enrolment in this study Concurrent enrolment in a research protocol investigating experimental pharmacologic treatments for depression at this or any other institution
Interventions	Ketamine versus diphenhydramine
Outcomes	Primary outcome measures: Evaluate the effects of ketamine on depressive symptomatology. Time frame: 0 ‐ 16 weeks. [Designated as safety issue: No]. Montgomery‐Asberg Depressive Rating Scale
Starting date	December 2013
Contact information	mailto:stephen.ross%40nyumc.org?subject=NCT02106325, S13‐00794, Ketamine as a Rapidly‐Acting Antidepressant in Depressed Emergency Department Patients
Notes	NCT02106325