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Emergency Ketamine Treatment of Suicidal Ideation

Primary Purpose

Depression, Suicidal Ideation, Suicidal Impulses

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intranasal Ketamine
Intranasal Saline Placebo
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Suicidal Ideation, Ketamine, Emergency Department

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of CincinnatiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intranasal Ketamine

Intranasal Saline Placebo

Arm Description

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.

0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 2, 2014
Last Updated
August 3, 2016
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT02183272
Brief Title
Emergency Ketamine Treatment of Suicidal Ideation
Official Title
Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicidal Ideation, Suicidal Impulses
Keywords
Depression, Suicidal Ideation, Ketamine, Emergency Department

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intranasal Ketamine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intranasal Saline Placebo
Arm Type
Placebo Comparator
Arm Description
0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.
Intervention Type
Drug
Intervention Name(s)
Intranasal Ketamine
Other Intervention Name(s)
ketamine
Intervention Description
Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.
Intervention Type
Drug
Intervention Name(s)
Intranasal Saline Placebo
Other Intervention Name(s)
saline
Intervention Description
Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.
Primary Outcome Measure Information:
Title
Ketamine effect on Suicidal Ideation and Depression.
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Assessment of Role of Mu Opioid Receptor
Description
To assess the role of specific mu opioid receptor genetic variants in prediction of response to ketamine to alleviate suicidal ideation.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Assessment of Changes of Biological Markers
Description
To assess the changes in biological markers of suicide risk such as linguistic patterns, voice and facial movements after ketamine treatment compared to baseline.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faryal Mallick
Phone
513-558-4997
Email
mallicfl@ucmail.uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl McCullumsmith, MD PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faryal Mallick, MD
Phone
513-558-4997
Email
mallicfl@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Cheryl McCullumsmith, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33583341
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.
Results Reference
derived

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Emergency Ketamine Treatment of Suicidal Ideation

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