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Emergency Ketamine Treatment of Suicidal Ideation

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ClinicalTrials.gov Identifier: NCT02183272
Recruitment Status : Unknown
Verified August 2016 by Cheryl McCullumsmith, University of Cincinnati.
Recruitment status was:  Recruiting
First Posted : July 8, 2014
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Cheryl McCullumsmith, University of Cincinnati

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date August 5, 2016
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
Ketamine effect on Suicidal Ideation and Depression. [ Time Frame: 4 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
Ketamine effect on Suicidal Ideation and Depression. [ Time Frame: 4 weeks ]
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-Asburg Depression Rating Scale (MADRS)as compared to placebo.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
Assessment of Role of Mu Opioid Receptor [ Time Frame: 4 weeks ]
To assess the role of specific mu opioid receptor genetic variants in prediction of response to ketamine to alleviate suicidal ideation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 2, 2014)
Assessment of Changes of Biological Markers [ Time Frame: 4 weeks ]
To assess the changes in biological markers of suicide risk such as linguistic patterns, voice and facial movements after ketamine treatment compared to baseline.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Emergency Ketamine Treatment of Suicidal Ideation
Official Title  ICMJE Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Suicidal Ideation
  • Suicidal Impulses
Intervention  ICMJE
  • Drug: Intranasal Ketamine
    Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.
    Other Name: ketamine
  • Drug: Intranasal Saline Placebo
    Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.
    Other Name: saline
Study Arms  ICMJE
  • Active Comparator: Intranasal Ketamine
    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.
    Intervention: Drug: Intranasal Ketamine
  • Placebo Comparator: Intranasal Saline Placebo
    0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.
    Intervention: Drug: Intranasal Saline Placebo
Publications * 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. 2021 Feb 14:1-16. doi: 10.1080/13811118.2021.1878078. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 2, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02183272
Other Study ID Numbers  ICMJE Ketamine IIT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cheryl McCullumsmith, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cheryl McCullumsmith, MD PhD University of Cincinnati
PRS Account University of Cincinnati
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP