Emergency Ketamine Treatment of Suicidal Ideation

University of Cincinnati60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depression Suicidal Ideation Suicidal Impulses

Interventions

Intranasal KetamineDRUG

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 PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Cincinnati

Cincinnati, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 4 weeks

Secondary Outcomes

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.

Time frame: 4 weeks

Central Contacts

Faryal Mallick

CONTACT

513-558-4997 mallicfl@ucmail.uc.edu

Data from ClinicalTrials.gov

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