Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

The University of Alabama at Birmingham

Status: Completed

Conditions: Suicidal Ideation; Depression

Treatments: Drug: placebo; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01887990

F120307001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 4 patient groups, including a placebo group

Suicidal, Depression with Ketamine

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

Suicidal, Depression with Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

Suicidal, opioid use with ketamine

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

Suicidal, opioid use with Saline

Placebo Comparator group

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

Treatment:

Drug: placebo