Intramuscular Ketamine for Suicidal Ideation

Mount Sinai Health System

Status and phase: Withdrawn; Phase 2

Conditions: Suicidal Ideation

Treatments: Drug: Placebo; Drug: Ketamine (Ketalar)

Study type: Interventional

Funder types: Other

Identifiers

NCT05105061

STUDY-20-01496

21-1174 (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Ketamine (1) then Placebo (2)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Ketamine (Ketalar)

Placebo (1) then Ketamine (2)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Ketamine (Ketalar)