Emergency Ketamine Treatment of Suicidal Ideation

Phase 2

• Conditions: Suicidal Ideation; Depression; Suicidal Impulses
• Interventions: Drug: Intranasal Ketamine; Drug: Intranasal Saline Placebo

• Registration Number: NCT02183272
• Lead Sponsor: University of Cincinnati

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-08
• Status Verified: 2016-08
• Study Start: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-05
• Primary Completion: 2017-11
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Ketamine	Intranasal Ketamine	0.2 mg / kg dose of intranasal ketamine for treatment of suicidality will be given in two separate doses on the day of admission to the hospital.
Intranasal Saline Placebo	Intranasal Saline Placebo	0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.

Primary Outcome Measures

Name	Time	Method
Ketamine effect on Suicidal Ideation and Depression.	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of Role of Mu Opioid Receptor	4 weeks	To assess the role of specific mu opioid receptor genetic variants in prediction of response to ketamine to alleviate suicidal ideation.

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States