A Study to Decrease Suicidal Thinking Using Ketamine

• Status: Withdrawn
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Depression treatment typically is slow acting. Patients presenting with acute suicidality have few immediate treatment options. However, sub-anesthetic doses of ketamine have been now widely tested as a rapid-acting treatment for depression. Gregory Larkin et al at Yale showed this could be applied to suicidal patients, with 14 of 15 participants showing remission of suicidal thinking within 40 min of the administration of ketamine, with 13 showing lasting remission out to 10 days. No serious side effects were reported. This project proposes to conduct a randomized, placebo-controlled trial of this, same intervention in military patients recently hospitalized for suicidal thinking. After being assessed, and giving informed consent, participants would receive 0.2mg/kg ketamine or placebo. Their suicidal thinking, depression, and other symptoms would be monitored acutely for 240 min after drug infusion, and the for lasting changes the next day, at hospital discharge, 2 weeks, and 10 weeks. Potential adverse events will be monitored via the electronic medical record for up to a year.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United States Naval Medical Center, San Diego
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• Voluntarily, psychiatrically hospitalized at NMCSD within the last 12 hours for suicidal thinking

• BSS greater than 4

• BHS greater than 8

• BDI greater than 19

• Ability to give informed consent

• Active duty military status

• Verified negative pregnancy test for females

Exclusion Criteria:

• Psychosis or bipolar disorder

• Pregnancy

• Involuntary status on presentation to the ED

• Positive for illicit drugs of abuse

• Blood alcohol level greater than zero

• Previous enrollees in this treatment protocol will be excluded from repeat participation

• Any patient brought for command directed psychiatric evaluation

• Specific contraindication to the use of ketamine are as follows and under such circumstances or conditions, personnel with the following should be excluded from participation in this study:

A) patients with elevated intracranial pressure, uncontrolled hypertension, coronary artery disease, aneurysms, thyrotoxicosis, congestive heart failure (CHF), a recent history of head or eye injury, or angina B) all personnel in whom a significant elevation of blood pressure would constitute a serious hazard to their overall health and well-being C) patients currently utilizing the following medications: conivaptan, dasatinib, peginterferon alfa-2b, quazepam, tocilizumab