A Study to Decrease Suicidal Thinking Using Ketamine

NCT02418702 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-09-03

No results posted yet for this study

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

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02418702 on ClinicalTrials.gov