Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring
Overview
- Phase
- Phase 2
- Intervention
- Ketamine (Ketalar)
- Conditions
- Suicidal Ideation
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Locations
- 1
- Primary Endpoint
- Change in Auditory Mismatch Negativity (EEG)
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
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.
Investigators
Matthew Klein
Assistant Professor
Icahn School of Medicine at Mount Sinai
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
Exclusion Criteria
- Not provided
Arms & Interventions
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)
Intervention: Ketamine (Ketalar)
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)
Intervention: Placebo
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
Intervention: Ketamine (Ketalar)
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
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Auditory Mismatch Negativity (EEG)
Time Frame: Baseline and One hour post injection
Change in Mismatch Negativity (MMN) amplitude or latency from baseline up to one hour after injection.
Secondary Outcomes
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI)(Baseline and 24 hours post injection)