Ketamine in the Treatment of Suicidal Depression
This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from depression.
The first drug, Ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts.
Major Depressive Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Ketamine vs. Midazolam: Testing Rapid Relief of Suicide Risk in Depression|
- 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.
- Effects on saliva stress hormone (cortisol) [ Time Frame: 24 hours post-infusion ] [ Designated as safety issue: No ]Effects on levels of the stress hormone cortisol in saliva from before to 24 hours after the infusion.
- Neuropsychological effects [ Time Frame: 24 hours post-infusion ] [ Designated as safety issue: No ]Effects of the infusion on neuropsychological variables including decision-making and memory.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Midazolam
0.02 mg/kg, I.V. (in the vein)
Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
Other Name: Midazolam Injection
Active Comparator: Ketamine
0.5 mg/kg, I.V. (in the vein)
Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes
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 2mg 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 enrollment 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.
|Contact: Abbey R. Frawley, B.A.||firstname.lastname@example.org|
|United States, New York|
|Columbia University/New York State Psychiatric Institute||Recruiting|
|New York, New York, United States, 10032|
|Contact: Abbey Frawley, B.A. 212-543-6708 email@example.com|
|Principal Investigator: Michael F. Grunebaum, M.D.|
|Principal Investigator:||Michael F. Grunebaum, M.D.||Columbia University/New York State Psychiatric Institute|