Emergency Ketamine Treatment of Suicidal Ideation

Sponsor

University of Cincinnati (Other)

Overall Status

Unknown status

CT.gov ID

NCT02183272

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Suicidal Ideation Suicidal Impulses	Drug: Intranasal Ketamine Drug: Intranasal Saline Placebo	Phase 2/Phase 3

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2017

Anticipated Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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. Other Names: ketamine
Placebo Comparator: Intranasal Saline Placebo 0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.	Drug: Intranasal Saline Placebo Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation. Other Names: saline

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Other Names:

ketamine

Placebo Comparator: Intranasal Saline Placebo

0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.

Drug: Intranasal Saline Placebo

Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.

Other Names:

saline

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Assessment of Changes of Biological Markers [4 weeks]
To assess the changes in biological markers of suicide risk such as linguistic patterns, voice and facial movements after ketamine treatment compared to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males and females
Ages 18-65
All races and ethnicities
Willing and able to provide informed consent
A cutoff score of >3 on the Beck Scale for Suicidal Ideation
2 on the Columbia Scale for Suicide Severity Rating

Exclusion Criteria:

Pregnancy or lactation; women of reproductive potential must have a negative urine pregnancy test
Post-partum state (within 2 months of delivery)
Homicide risk as determined by clinical interview
Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses:
Any current primary psychotic disorder
Acute intoxication or withdrawal from alcohol or any other substance of abuse, as determined by clinical interview and urine drug screen except opioids
use of any hallucinogen (except cannabis), in the last month
Any dissociative disorder
Pervasive developmental disorder
Cognitive disorder
Cluster A personality disorder
Anorexia nervosa.
Treatment with any medication known to affect the N-methyl-D-aspartate (NMDA) receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium)
Any known hypersensitivity or serious adverse effect with ketamine
Any clinically-significant medication or condition that would preclude the use of ketamine