Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

NCT ID: NCT01887990

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-01-31

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.

Conditions

Depression; Suicidal Ideation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Suicidal, Depression with Ketamine

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

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

single dose IV 0.2 mg/kg ketamine

Suicidal, Depression with Saline

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

saline infusion

Suicidal, opioid use with ketamine

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

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

single dose IV 0.2 mg/kg ketamine

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

saline infusion

Interventions

Ketamine

single dose IV 0.2 mg/kg ketamine

Intervention Type: DRUG

placebo

saline infusion

Intervention Type: DRUG

Other Intervention Names

saline

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Dr. Richard Shelton

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheryl B McCullumsmith, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F120307001

Identifier Type: -

Identifier Source: org_study_id