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WithdrawnPhase 2

Intramuscular Ketamine for Suicidal Ideation

NCT05105061 · Icahn School of Medicine at Mount Sinai

Closed to entry
Status
Not accepting participants
Phase 2
Phase
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Auditory Mismatch Negativity (EEG)

    Measured over Baseline and One hour post injection

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Icahn School of Medicine at Mount SinaiNew YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT05105061 on ClinicalTrials.gov →

Last updated in the registry 2022-04-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits