NCT01944293

Ketamine for Suicidality in Bipolar Depression

Ketamine vs. Midazolam in Bipolar Depression

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar 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.

Detailed description

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. 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). After the infusion(s), participants will have weekly research interviews for 6 weeks to monitor response. After post-infusion research measures are completed, all subjects will receive open clinical treatment. During open clinical treatment, medication will be changed for those patients who don't respond or whose response is transient. 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 combining inpatient and outpatient treatment. At the end of the 6 months of treatment patients will be referred for ongoing care.

Conditions

• Bipolar Disorder
• Major Depressive Episode
• Suicidal Ideation

Interventions

Type	Name	Description
DRUG	Ketamine	Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes
DRUG	Midazolam	Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-09-01
• Completion: 2018-10-01
• First posted: 2013-09-17
• Last updated: 2020-03-11
• Results posted: 2019-06-06

Locations

1 site across 1 country: United States