Emergency Ketamine Treatment of Suicidal Ideation

Depression Clinical Trial

Official title:

Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02183272
• Other study ID #: Ketamine IIT
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 2, 2014
• Last updated: August 3, 2016
• Start date: August 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2016
• Source: University of Cincinnati
• Contact: Faryal Mallick
• Phone: 513-558-4997
• Email: mallicfl[@]ucmail.uc.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment.

Description:

The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Males and females

2. Ages 18-65

3. All races and ethnicities

4. Willing and able to provide informed consent

5. A cutoff score of >3 on the Beck Scale for Suicidal Ideation

6. >2 on the Columbia Scale for Suicide Severity Rating

Exclusion Criteria:

1. Pregnancy or lactation; women of reproductive potential must have a negative urine pregnancy test

2. Post-partum state (within 2 months of delivery)

3. Homicide risk as determined by clinical interview

4. Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses:

1. Any current primary psychotic disorder

2. Acute intoxication or withdrawal from alcohol or any other substance of abuse, as determined by clinical interview and urine drug screen except opioids

3. use of any hallucinogen (except cannabis), in the last month

4. Any dissociative disorder

5. Pervasive developmental disorder

6. Cognitive disorder

7. Cluster A personality disorder

8. Anorexia nervosa.

5. Treatment with any medication known to affect the N-methyl-D-aspartate (NMDA) receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium)

6. Any known hypersensitivity or serious adverse effect with ketamine

7. Any clinically-significant medication or condition that would preclude the use of ketamine

Study Design

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

Related Conditions & MeSH terms

• Depression
• Emergencies
• Suicidal Ideation
• Suicidal Impulses

Intervention

Drug:
• Intranasal Ketamine
Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.
• Intranasal Saline Placebo
Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of Changes of Biological Markers	To assess the changes in biological markers of suicide risk such as linguistic patterns, voice and facial movements after ketamine treatment compared to baseline.	4 weeks	No
Primary	Ketamine effect on Suicidal Ideation and Depression.	To assess the acute efficacy and durability of effect over a 4 week time period of single dose of 0.2 mg/kg intranasal ketamine treatment on suicidal ideation and depression in individuals with acute suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS) and the Montgomery-Asberg Depression Rating Scale (MADRS)as compared to placebo.	4 weeks	No
Secondary	Assessment of Role of Mu Opioid Receptor	To assess the role of specific mu opioid receptor genetic variants in prediction of response to ketamine to alleviate suicidal ideation.	4 weeks	No