Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

Depression Clinical Trial

Official title:

Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887990
• Other study ID #: F120307001
• Status: Completed
• Phase: N/A
• First received: August 7, 2012
• Last updated: June 17, 2015
• Start date: May 2012
• Est. completion date: January 2014

Study information

• Verified date: June 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Suicidal Ideation

Intervention

Drug:
• Ketamine
single dose IV 0.2 mg/kg ketamine
• placebo
saline infusion

Locations

Country	Name	City	State
United States	University of Alabama Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No