Intramuscular Ketamine for Suicidal Ideation

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05105061
Collaborator
(none)
0
1
2
1.7
0

Study Details

Study Description

Brief Summary

The objective of the present research protocol, a cross-over, subject-blinded, clinical trial, is to correlate changes in brain activity with reduction in suicidal ideation in response to a single intramuscular dose of ketamine. While ketamine is increasingly used as a rapid, antidepressant agent, there is accumulating evidence of additional anti-suicidal properties that may be distinct from its effects on depression. This pilot study will be used to determine (1) whether specific electroencephalogram (EEG) findings are correlated with response of SI to intramuscular (IM) ketamine, and (2) the effectiveness of IM ketamine in the treatment of acute SI.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ketamine (Ketalar)
  • Drug: Placebo
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring
Anticipated Study Start Date :
Feb 1, 2022
Actual Primary Completion Date :
Mar 24, 2022
Actual Study Completion Date :
Mar 24, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ketamine (1) then Placebo (2)

Participants will receive an intramuscular injection of racemic ketamine, followed the next day by an intramuscular injection of saline (placebo)

Drug: Ketamine (Ketalar)
0.5 mg/kg of body weight

Drug: Placebo
IM injection of matching placebo

Placebo Comparator: Placebo (1) then Ketamine (2)

Participants will receive an intramuscular injection of saline (placebo), followed the next day by an intramuscular injection of racemic ketamine

Drug: Ketamine (Ketalar)
0.5 mg/kg of body weight

Drug: Placebo
IM injection of matching placebo

Outcome Measures

Primary Outcome Measures

  1. Change in Auditory Mismatch Negativity (EEG) [Baseline and One hour post injection]

    Change in Mismatch Negativity (MMN) amplitude or latency from baseline up to one hour after injection.

Secondary Outcome Measures

  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI) [Baseline and 24 hours post injection]

    Change in MADRS #10 from baseline to 24 hours post-injection. Score range from 0-5, with higher score indicating higher severity of symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Current clinically significant suicidal ideation, defined as a score of > or = 4 on the MADRS item 10 and a positive answer on items 3,4 or 5 of the C-SSRS.

  • Inpatient status at the time of study initiation.

  • 18 to 70 years of age

  • Capacity to consent

Exclusion criteria:
  • Diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder)

  • Diagnosis of pervasive developmental disorder

  • Diagnosis of a major neurocognitive disorder

  • A positive urine pregnancy test

  • Currently breastfeeding

  • Drug or alcohol abuse or dependence within the preceding 3 months; a rather narrow time period was chosen, however, in order to allow participation by individuals with a history of substance abuse or dependence problems that could be secondary to their SI, and to more closely approximate patients seen in real-world settings. Given the increasingly widespread use of marijuana, and in an effort to recruit a naturalistic study population, concurrent marijuana use is not an exclusion criterion, as long as they are not actively intoxicated.

  • Current positive UTOX for amphetamine, benzodiazepines, cocaine, opiates (if not prescribed)

  • Medical issues or laboratory abnormalities requiring acute intervention

  • Patients for whom an increase in blood pressure or intracranial pressure would pose a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, unstable angina)

  • Any lifetime history of ketamine or phencyclidine abuse

  • A known hypersensitivity to or history of a serious adverse effect from to ketamine

Contacts and Locations

Locations

Site City State Country Postal Code
1 Icahn School of Medicine at Mount Sinai New York New York United States 10029

Sponsors and Collaborators

  • Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Matthew Klein, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matthew Klein, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT05105061
Other Study ID Numbers:
  • STUDY-20-01496
  • 21-1174
First Posted:
Nov 3, 2021
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Matthew Klein, Assistant Professor, Icahn School of Medicine at Mount Sinai
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022