Clinical trial NCT02183272: Emergency Ketamine Treatment of Suicidal Ideation
Official title: Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Depression
Suicidal Ideation
Suicidal Impulses
Keywords: Depression
Suicidal Ideation
Ketamine
Emergency Department
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Males and females
2. Ages 18-65
3. All races and ethnicities
4. Willing and able to provide informed consent
5. A cutoff score of \>3 on the Beck Scale for Suicidal Ideation
6. \>2 on the Columbia Scale for Suicide Severity Rating

Exclusion Criteria:

1. Pregnancy or lactation; women of reproductive potential must have a negative urine pregnancy test
2. Post-partum state (within 2 months of delivery)
3. Homicide risk as determined by clinical interview
4. Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses:

   1. Any current primary psychotic disorder
   2. Acute intoxication or withdrawal from alcohol or any other substance of abuse, as determined by clinical interview and urine drug screen except opioids
   3. use of any hallucinogen (except cannabis), in the last month
   4. Any dissociative disorder
   5. Pervasive developmental disorder
   6. Cognitive disorder
   7. Cluster A personality disorder
   8. Anorexia nervosa.
5. Treatment with any medication known to affect the N-methyl-D-aspartate (NMDA) receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium)
6. Any known hypersensitivity or serious adverse effect with ketamine
7. Any clinically-significant medication or condition that would preclude the use of ketamine

Primary outcomes:
measure: Ketamine effect on Suicidal Ideation and Depression.
timeFrame: 4 weeks
Secondary outcomes:
measure: Assessment of Role of Mu Opioid Receptor
timeFrame: 4 weeks
Other outcomes:
measure: Assessment of Changes of Biological Markers
timeFrame: 4 weeks
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Cheryl McCullumsmith, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.