Emergency Ketamine Treatment of Suicidal Ideation

August 3, 2016 updated by: Cheryl McCullumsmith, University of Cincinnati

Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.

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 Overview

Status

Unknown

Conditions

Intervention / 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

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati
        • Contact:
        • Principal Investigator:
          • Cheryl McCullumsmith, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Investigators

  • Principal Investigator: Cheryl McCullumsmith, MD PhD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ketamine IIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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