Emergency Ketamine Treatment of Suicidal Ideation
Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 depression
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 8, 2014
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 5, 2016
August 1, 2016
1.3 years
July 2, 2014
August 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Assessment of Role of Mu Opioid Receptor
4 weeks
Other Outcomes (1)
Assessment of Changes of Biological Markers
4 weeks
Study Arms (2)
Intranasal Ketamine
ACTIVE COMPARATOR0.2 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 COMPARATOR0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.
Interventions
Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.
Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Related Publications (1)
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.
PMID: 33583341DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryl McCullumsmith, MD PhD
University of Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 2, 2014
First Posted
July 8, 2014
Study Start
August 1, 2016
Primary Completion
November 1, 2017
Study Completion
July 1, 2018
Last Updated
August 5, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share