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Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Depression Suicidal Ideation Drug: Ketamine Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Suicidal Ideation With Intravenous Ketamine Infusion
Actual Study Start Date : May 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Ketamine

Arm Intervention/treatment
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
Drug: Ketamine
single dose IV 0.2 mg/kg ketamine

Placebo Comparator: Suicidal, Depression with Saline
Suicidal ideation and depression (no substance use disorder) comparable amount of placebo (saline)
Drug: placebo
saline infusion
Other Name: saline

Active Comparator: Suicidal, opioid use with ketamine
suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose
Drug: Ketamine
single dose IV 0.2 mg/kg 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
Drug: placebo
saline infusion
Other Name: saline




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01887990


Locations
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United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35205
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Cheryl B McCullumsmith, MD PhD University of Alabama at Birmingham
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Responsible Party: Dr. Richard Shelton, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01887990    
Other Study ID Numbers: F120307001
First Posted: June 27, 2013    Key Record Dates
Results First Posted: July 9, 2015
Last Update Posted: May 15, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Ketamine
Suicidal Ideation
Behavioral Symptoms
Suicide
Self-Injurious Behavior
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