Intramuscular Ketamine for Suicidal Ideation

Study Overview
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Brief Summary
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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.

Official Title
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Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring

Conditions
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Suicidal Ideation

Intervention / Treatment
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* Drug: Ketamine (Ketalar)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine (1) then Placebo (2)<br>Participants will receive an intramuscular injection of racemic ketamine, followed the next day by an intramuscular injection of saline (placebo) | Drug: Ketamine (Ketalar)<br>* 0.5 mg/kg of body weight<br>Drug: Placebo<br>* IM injection of matching placebo<br>|
| Placebo Comparator: Placebo (1) then Ketamine (2)<br>Participants will receive an intramuscular injection of saline (placebo), followed the next day by an intramuscular injection of racemic ketamine | Drug: Ketamine (Ketalar)<br>* 0.5 mg/kg of body weight<br>Drug: Placebo<br>* IM injection of matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Auditory Mismatch Negativity (EEG) | Change in Mismatch Negativity (MMN) amplitude or latency from baseline up to one hour after injection. | Baseline and One hour post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI) | Change in MADRS #10 from baseline to 24 hours post-injection. Score range from 0-5, with higher score indicating higher severity of symptoms. | Baseline and 24 hours post injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide, EEG, Ketamine