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.
Emergency Ketamine Treatment of Suicidal Ideation
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.
Intervention / Treatment
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Intranasal ketamine (DRUG)Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.
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Intranasal Saline Placebo (DRUG)Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.
Condition or Disease
- Depression
- Suicidal Ideation
- Suicidal Impulses
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Unknown status |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 60 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
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Clinical Trial Dates
| Start date: | Aug 01, 2016 | |
|---|---|---|
| Primary Completion: | Nov 01, 2017 | ESTIMATED |
| Completion Date: | Jul 01, 2018 | ESTIMATED |
| Study First Posted: | Jul 08, 2014 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Aug 03, 2016 |
Sponsors / Collaborators
Lead Sponsor:
University of Cincinnati
Responsible Party:
N/A
Location
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
Participant Groups
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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.
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0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
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
Primary Outcomes
Secondary Outcomes
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To assess the role of specific mu opioid receptor genetic variants in prediction of response to ketamine to alleviate suicidal ideation.
Other Outcomes
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To assess the changes in biological markers of suicide risk such as linguistic patterns, voice and facial movements after ketamine treatment compared to baseline.
More Details
| NCT Number: | NCT02183272 |
|---|---|
| Other IDs: | Ketamine IIT |
| Study URL: | https://clinicaltrials.gov/study/NCT02183272 |
Last updated: Sep 29, 2023