A Study to Decrease Suicidal Thinking Using Ketamine
NCT02418702 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2019-09-03
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.
Conditions
- Depression
- Suicide
Interventions
- DRUG
-
0.2 mg/kg ketamine
20 patients will randomly be assigned 0.2 mg/kg of Ketamine
- OTHER
-
placebo
20 patients will randomly be assigned a placebo
Sponsors & Collaborators
-
United States Naval Medical Center, San Diego
lead FED
Principal Investigators
-
Marc A Capobianco · United States Naval Medical Center, San Diego
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2016-08-31
- Completion
- 2017-08-31
Countries
- United States
Study Locations
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