Emergency Ketamine Treatment of Suicidal Ideation

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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

Official Title
-----------------
Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.

Conditions
-----------------
Depression, Suicidal Ideation, Suicidal Impulses

Intervention / Treatment
-----------------
* Drug: Intranasal Ketamine
* Drug: Intranasal Saline Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Ages 18-65 All races and ethnicities Willing and able to provide informed consent A cutoff score of >3 on the Beck Scale for Suicidal Ideation >2 on the Columbia Scale for Suicide Severity Rating 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: Any current primary psychotic disorder Acute intoxication or withdrawal from alcohol or any other substance of abuse, as determined by clinical interview and urine drug screen except opioids use of any hallucinogen (except cannabis), in the last month Any dissociative disorder Pervasive developmental disorder Cognitive disorder Cluster A personality disorder Anorexia nervosa. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intranasal Ketamine<br>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. | Drug: Intranasal Ketamine<br>* Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.<br>* Other names: ketamine;|
| Placebo Comparator: Intranasal Saline Placebo<br>0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission. | Drug: Intranasal Saline Placebo<br>* Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.<br>* Other names: saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Suicidal Ideation, Ketamine, Emergency Department