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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depression Suicidal Ideation Suicidal Impulses Drug: Intranasal Ketamine Drug: Intranasal Saline Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.
Study Start Date : August 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183272


Contacts
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Contact: Faryal Mallick 513-558-4997 mallicfl@ucmail.uc.edu

Locations
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United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Faryal Mallick, MD    513-558-4997    mallicfl@ucmail.uc.edu   
Principal Investigator: Cheryl McCullumsmith, MD PhD         
Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Cheryl McCullumsmith, MD PhD University of Cincinnati
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cheryl McCullumsmith, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02183272    
Other Study ID Numbers: Ketamine IIT
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cheryl McCullumsmith, University of Cincinnati:
Depression
Suicidal Ideation
Ketamine
Emergency Department
Additional relevant MeSH terms:
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Emergencies
Depression
Suicidal Ideation
Behavioral Symptoms
Disease Attributes
Pathologic Processes
Suicide
Self-Injurious Behavior
Ketamine
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action