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The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment.
The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Ketamine | Active Comparator | 0.2 mg / kg dose of intranasal ketamine for treatment of suicidality will be given in two separate doses on the day of admission to the hospital. |
|
| Intranasal Saline Placebo | Placebo Comparator | 0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Ketamine | Drug | Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ketamine effect on Suicidal Ideation and Depression. | To assess the acute efficacy and durability of effect over a 4 week time period of single dose of 0.2 mg/kg intranasal ketamine treatment on suicidal ideation and depression in individuals with acute suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS) and the Montgomery-Asberg Depression Rating Scale (MADRS)as compared to placebo. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Role of Mu Opioid Receptor | To assess the role of specific mu opioid receptor genetic variants in prediction of response to ketamine to alleviate suicidal ideation. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Changes of Biological Markers | To assess the changes in biological markers of suicide risk such as linguistic patterns, voice and facial movements after ketamine treatment compared to baseline. | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
Pregnancy or lactation; women of reproductive potential must have a negative urine pregnancy test
Post-partum state (within 2 months of delivery)
Homicide risk as determined by clinical interview
Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses:
Treatment with any medication known to affect the N-methyl-D-aspartate (NMDA) receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium)
Any known hypersensitivity or serious adverse effect with ketamine
Any clinically-significant medication or condition that would preclude the use of ketamine
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faryal Mallick | Contact | 513-558-4997 | mallicfl@ucmail.uc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cheryl McCullumsmith, MD PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33583341 | Derived | Domany Y, McCullumsmith CB. Single, Fixed-Dose Intranasal Ketamine for Alleviation of Acute Suicidal Ideation. An Emergency Department, Trans-Diagnostic Approach: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial. Arch Suicide Res. 2022 Jul-Sep;26(3):1250-1265. doi: 10.1080/13811118.2021.1878078. Epub 2021 Feb 14. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Intranasal Saline Placebo | Drug | Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation. |
|
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |