NCT01700829.

Study name	Ketamine versus midazolam: testing rapid relief of suicide risk in depression
Methods	Allocation: randomised Endpoint classification: efficacy study Intervention model: parallel assignment Masking: double‐blind (participant, caregiver, investigator, outcomes assessor) Patients currently taking psychiatric medications may continue them during the study. However, if a patient is taking a benzodiazepine (such as ativan, klonopin, or xanax), they will be able to take up to 2 mg per day of lorazepam during the week before the infusion, but none will be permitted in the 24 hours pre‐infusion. Also, zolpidem (ambien) will not be permitted in the 24 hours pre‐infusion. If a person chooses to participate, their dose of benzodiazepine may need to be reduced so that they can do without it during the 24 hours pre‐infusion Depressed participants are randomly assigned to receive a single dose of ketamine(0.5 mg/kg) or midazolam (0.02 mg/kg), which is given slowly, in a vein, over about 40 minutes. The study is "double‐blind," meaning patients and study staff will not know which medication is in the infusion If a patient does not respond to the first infusion, and s/he received midazolam, then s/he will be offered the option of a second infusion, this time with ketamine (0.5 mg/kg). S/he will then start treatment with a standard antidepressant, unless s/he is not already taking one. After the infusion(s), participants will have weekly research interviews for 6 weeks to monitor response. If a patient does have a sufficient infusion response, and s/he is not already taking an antidepressant, then s/he will receive 6 weeks antidepressant research treatment with Sertraline, Fluoxetine, Paroxetine, or Escitalopram, followed by open clinical treatment. However, if s/he is already taking an antidepressant, then s/he will receive open treatment. If s/he does not have a sufficient infusion response, then s/he will receive open treatment Participation in this study requires a brief inpatient stay, at no cost, at the New York State Psychiatric Institute (NYSPI) Eligible participants enrolled in this study will be offered medication management visits at no cost for a total of up to 6 months from the date of enrolment combining inpatient and outpatient treatment. Study medications (sertraline, fluoxetine, paroxetine, escitalopram, lorazepam, zolpidem) will be at no cost during the 6 months. The study will not provide other medications at no cost
Participants	Inclusion criteria Unipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication‐free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation (See 2) Moderate to severe suicidal ideation 18‐65 years old Participants must agree to a voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for the infusion(s), for a brief stay, or longer if clinically necessary Pre‐menopausal female participants of child‐bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, or oral contraceptive pills Able to provide informed consent Participants 61‐65 years old must score a 25 or higher on the Mini‐Mental State Examination (MMSE) at screening EXxclusion criteria Unstable medical condition or neurological illness, including baseline hypertension (BP > 140/90) or significant history of cardiovascular illness Significant ECG abnormality Pregnant or lactating Diagnosis of bipolar disorder or psychotic disorder Contraindication to any study treatment. Inadequate understanding of English. Prior ineffective trial of or adverse reaction to ketamine or midazolam. Opiate use greater than total daily dose of 20 mg oxycodone or equivalent during the 3 days pre‐infusion A diagnosis of sleep apnoea
Interventions	Ketamine versus midazolam
Outcomes	Primary outcome measures: reduction of suicidal ideation. Time frame: At 24 hours post‐infusion. [Designated as safety issue: No]. Reduction of suicidal ideation in depressed patients with moderate to severe suicidal thoughts from the pre‐infusion baseline to 24 hours after the infusion with ketamine or midazolam, a sedative not known to reduce suicidal ideation
Starting date	June 2012
Contact information	mailto:marverj%40nyspi.columbia.edu?subject=NCT01700829, #6598, Ketamine in the Treatment of Suicidal Depression
Notes	NCT01700829