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.

Study Overview

• Status: Completed
• Conditions: Depression; Suicidal Ideation
• Intervention / Treatment: Drug: Ketamine; Drug: placebo

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: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • University of Alabama Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 hours

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: June 26, 2013
• First Posted (Estimate): June 27, 2013

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: F120307001