Suicidal Ideation
Conditions
Keywords
Suicide, EEG, Ketamine
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.
Interventions
0.5 mg/kg of body weight
DRUGPlacebo
IM injection of matching placebo
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Auditory Mismatch Negativity (EEG) | Baseline and One hour post injection | Change in Mismatch Negativity (MMN) amplitude or latency from baseline up to one hour after injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI) | Baseline and 24 hours post injection | Change in MADRS #10 from baseline to 24 hours post-injection. Score range from 0-5, with higher score indicating higher severity of symptoms. |
Countries
United States
Outcome results
None listed