Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

NCT01887990 | Completed Results

• 1 other identifier: F120307001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Depression

  2 hours

Study Arms (4)

Suicidal, Depression with Ketamine

ACTIVE COMPARATOR

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

Drug: Ketamine

Suicidal, Depression with Saline

PLACEBO COMPARATOR

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

Drug: placebo

Suicidal, opioid use with ketamine

ACTIVE COMPARATOR

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

Drug: Ketamine

Suicidal, opioid use with Saline

PLACEBO COMPARATOR

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

Interventions

Ketamine DRUG

single dose IV 0.2 mg/kg ketamine

Suicidal, Depression with Ketamine; Suicidal, opioid use with ketamine

placebo DRUG

saline infusion

Also known as: saline

Suicidal, Depression with Saline; Suicidal, opioid use with Saline

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama Birmingham

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Depression; Suicidal Ideation

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

short term followup small sample size

Results Point of Contact

• Title: Cheryl McCullumsmith
• Organization: University of Cincinnati

cheryl.mccullumsmith@uc.edu

513-5588022

Study Officials

• Cheryl B McCullumsmith, MD PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: June 27, 2013
• Study Start: May 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 15, 2017
• Results First Posted: July 9, 2015

Record last verified: 2017-04

Locations

US (1)