Clinical trial NCT01887990: Treatment of Suicidal Ideation With Intravenous Ketamine Infusion
Official title: Treatment of Suicidal Ideation With Intravenous Ketamine Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Suicidal Ideation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Suicidality
timeFrame: 2 hours
Secondary outcomes:
measure: Depression
timeFrame: 2 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Cheryl B McCullumsmith, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: