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Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

Primary Purpose

Depression, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketamine
placebo
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age : 19-64
  2. Significant suicidality score on the Columbia Suicide Severity Rating Scale (C-SSRS)
  3. Willing and able to provide informed consent.
  4. Individuals with current substance abuse are allowed

Exclusion Criteria:

  1. Pregnant or lactating; women of reproductive potential must have a negative urine pregnancy test (urine dipstick method)
  2. Post-Partum state : defined as being within 2 months of delivery or miscarriage
  3. Homicide risk as determined by clinical interview
  4. Treatment with any medication known to specifically target the glutamate-NMDA receptor system (ie lamotrigine, acamprosate, memantine, riluzole or lithium)
  5. Any known hypersensitivity or serious adverse effect associated with ketamine treatment.
  6. Any clinically significant medical condition or therapy that would preclude treatment with ketamine, to include recent myocardial infarction or unstable angina
  7. Medically unstable, including acute withdrawal from alcohol or benzodiazepines requiring the use of benzodiazepine treatment.

  8. Any of the following DSM-IV diagnoses or categories:

    • Any current psychosis or history of a non-mood psychotic disorder (e.g., schizophrenia)
    • Currently in a manic or mixed episode
    • Current use (defined by urine dipstick test) or abuse of hallucinogenic drugs (except marijuana) such as phencyclidine
    • Any dissociative disorder
    • Any pervasive developmental disorder (e.g., autism)
    • A cognitive disorder (e.g., Alzheimer's Disease)
    • Cluster A personality disorder (e.g., schizoid or schizotypal); note that cluster B and C personality disorders may be included
    • Any eating disorder

Sites / Locations

  • University of Alabama Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Suicidal, Depression with Ketamine

Suicidal, Depression with Saline

Suicidal, opioid use with ketamine

Suicidal, opioid use with Saline

Arm Description

suicidal ideation and depression (no substance use disorder) 0.2 mg/kg IV ketamine administered as a one time dose

Suicidal ideation and depression (no substance use disorder) comparable amount of placebo (saline)

suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose

Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm

Outcomes

Primary Outcome Measures

Suicidality
Scales and questionnaires using the Beck Scale for Suicidal Ideation. The Beck Scale is a self-report questionnaire. The items on this scale identify the presence and severity of suicidal ideation. Beck Scale for Suicidal Ideation has 19 items,preceded by a 5 item screener. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide.

Secondary Outcome Measures

Depression
Scales and Questionnaire using the MADRS (Montgomery-Asberg Depression Rating Scale) . This is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. the scale: 0 - 6 (normal/symptom absent), 7 - 19 (mild depression), 20 - 34 (moderate depression), and > 34 (severe depression).The overall score ranges from 0 to 60

Full Information

First Posted
August 7, 2012
Last Updated
April 7, 2017
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT01887990
Brief Title
Treatment of Suicidal Ideation With Intravenous Ketamine Infusion
Official Title
Treatment of Suicidal Ideation With Intravenous Ketamine Infusion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, the investigators are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression.
Detailed Description
This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, we are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression. Patients will be asked to participate in a research study to study how the use of a medication, ketamine, decreases your suicidal thoughts and improves their symptoms of depression. Ketamine is approved by FDA for use at higher doses in anesthesia, and recent clinical research suggests that it might benefit patients with major depressive disorder and suicidal thoughts. During clinical trials with over 10,000 patients, ketamine was proved to be safe as an anesthetic and studies with hundreds of patients with depression have demonstrated safety and lack of lasting side effects. This is a pilot study to test a new use of ketamine: treatment of suicidal thoughts. The study medication will be given in addition to usual psychiatric care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicidal Ideation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suicidal, Depression with Ketamine
Arm Type
Active Comparator
Arm Description
suicidal ideation and depression (no substance use disorder) 0.2 mg/kg IV ketamine administered as a one time dose
Arm Title
Suicidal, Depression with Saline
Arm Type
Placebo Comparator
Arm Description
Suicidal ideation and depression (no substance use disorder) comparable amount of placebo (saline)
Arm Title
Suicidal, opioid use with ketamine
Arm Type
Active Comparator
Arm Description
suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose
Arm Title
Suicidal, opioid use with Saline
Arm Type
Placebo Comparator
Arm Description
Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
single dose IV 0.2 mg/kg ketamine
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
saline
Intervention Description
saline infusion
Primary Outcome Measure Information:
Title
Suicidality
Description
Scales and questionnaires using the Beck Scale for Suicidal Ideation. The Beck Scale is a self-report questionnaire. The items on this scale identify the presence and severity of suicidal ideation. Beck Scale for Suicidal Ideation has 19 items,preceded by a 5 item screener. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Depression
Description
Scales and Questionnaire using the MADRS (Montgomery-Asberg Depression Rating Scale) . This is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. the scale: 0 - 6 (normal/symptom absent), 7 - 19 (mild depression), 20 - 34 (moderate depression), and > 34 (severe depression).The overall score ranges from 0 to 60
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age : 19-64 Significant suicidality score on the Columbia Suicide Severity Rating Scale (C-SSRS) Willing and able to provide informed consent. Individuals with current substance abuse are allowed Exclusion Criteria: Pregnant or lactating; women of reproductive potential must have a negative urine pregnancy test (urine dipstick method) Post-Partum state : defined as being within 2 months of delivery or miscarriage Homicide risk as determined by clinical interview Treatment with any medication known to specifically target the glutamate-NMDA receptor system (ie lamotrigine, acamprosate, memantine, riluzole or lithium) Any known hypersensitivity or serious adverse effect associated with ketamine treatment. Any clinically significant medical condition or therapy that would preclude treatment with ketamine, to include recent myocardial infarction or unstable angina Medically unstable, including acute withdrawal from alcohol or benzodiazepines requiring the use of benzodiazepine treatment. Any of the following DSM-IV diagnoses or categories: Any current psychosis or history of a non-mood psychotic disorder (e.g., schizophrenia) Currently in a manic or mixed episode Current use (defined by urine dipstick test) or abuse of hallucinogenic drugs (except marijuana) such as phencyclidine Any dissociative disorder Any pervasive developmental disorder (e.g., autism) A cognitive disorder (e.g., Alzheimer's Disease) Cluster A personality disorder (e.g., schizoid or schizotypal); note that cluster B and C personality disorders may be included Any eating disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl B McCullumsmith, MD PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States

12. IPD Sharing Statement

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Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

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