Clinical trial NCT05105061: Intramuscular Ketamine for Suicidal Ideation
Official title: Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Suicidal Ideation
Keywords: Suicide
EEG
Ketamine
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Auditory Mismatch Negativity (EEG)
timeFrame: Baseline and One hour post injection
Secondary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI)
timeFrame: Baseline and 24 hours post injection
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Matthew Klein
role: PRINCIPAL_INVESTIGATOR
References: