Depression, Suicidal Ideation, Suicidal Impulses
Conditions
Keywords
Depression, Suicidal Ideation, Ketamine, Emergency Department
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
Interventions
DRUGIntranasal 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 to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactFaryal Mallick
Outcome results
None listed