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Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

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ClinicalTrials.gov Identifier: NCT01887990
Recruitment Status : Completed
First Posted : June 27, 2013
Results First Posted : July 9, 2015
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Richard Shelton, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE August 7, 2012
First Posted Date  ICMJE June 27, 2013
Results First Submitted Date  ICMJE November 21, 2014
Results First Posted Date  ICMJE July 9, 2015
Last Update Posted Date May 15, 2017
Actual Study Start Date  ICMJE May 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2015)
Suicidality [ Time Frame: 2 hours ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
Suicidality [ Time Frame: 2 weeks ]
Scales and questionnaires Beck Scale for Suicidal Ideation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2015)
Depression [ Time Frame: 2 hours ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
Depression [ Time Frame: 2 weeks ]
Scales and Questionnaire MADRS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Suicidal Ideation With Intravenous Ketamine Infusion
Official Title  ICMJE Treatment of Suicidal Ideation With Intravenous Ketamine Infusion
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Suicidal Ideation
Intervention  ICMJE
  • Drug: Ketamine
    single dose IV 0.2 mg/kg ketamine
  • Drug: placebo
    saline infusion
    Other Name: saline
Study Arms  ICMJE
  • Active Comparator: Suicidal, Depression with Ketamine
    suicidal ideation and depression (no substance use disorder) 0.2 mg/kg IV ketamine administered as a one time dose
    Intervention: Drug: Ketamine
  • Placebo Comparator: Suicidal, Depression with Saline
    Suicidal ideation and depression (no substance use disorder) comparable amount of placebo (saline)
    Intervention: Drug: placebo
  • Active Comparator: Suicidal, opioid use with ketamine
    suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose
    Intervention: Drug: Ketamine
  • Placebo Comparator: Suicidal, opioid use with Saline
    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: Drug: placebo
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2015)
18
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2013)
100
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (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 NCT01887990
Other Study ID Numbers  ICMJE F120307001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Richard Shelton, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cheryl B McCullumsmith, MD PhD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date April 2017

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