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Completed

NCT Number: NCT01887990

Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama Birmingham

Birmingham, Alabama, 35205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

single dose IV 0.2 mg/kg ketamine

Placebo

Drug

saline infusion

Other names: saline

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 27, 2013
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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