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This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, the investigators are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression.
This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, we are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression. Patients will be asked to participate in a research study to study how the use of a medication, ketamine, decreases your suicidal thoughts and improves their symptoms of depression. Ketamine is approved by FDA for use at higher doses in anesthesia, and recent clinical research suggests that it might benefit patients with major depressive disorder and suicidal thoughts. During clinical trials with over 10,000 patients, ketamine was proved to be safe as an anesthetic and studies with hundreds of patients with depression have demonstrated safety and lack of lasting side effects. This is a pilot study to test a new use of ketamine: treatment of suicidal thoughts. The study medication will be given in addition to usual psychiatric care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suicidal, Depression with Ketamine | Active Comparator | suicidal ideation and depression (no substance use disorder) 0.2 mg/kg IV ketamine administered as a one time dose |
|
| Suicidal, Depression with Saline | Placebo Comparator | Suicidal ideation and depression (no substance use disorder) comparable amount of placebo (saline) |
|
| Suicidal, opioid use with ketamine | Active Comparator | suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose |
|
| Suicidal, opioid use with Saline | Placebo Comparator | Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | single dose IV 0.2 mg/kg ketamine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Suicidality | Scales and questionnaires using the Beck Scale for Suicidal Ideation. The Beck Scale is a self-report questionnaire. The items on this scale identify the presence and severity of suicidal ideation. Beck Scale for Suicidal Ideation has 19 items,preceded by a 5 item screener. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Scales and Questionnaire using the MADRS (Montgomery-Asberg Depression Rating Scale) . This is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. the scale: 0 - 6 (normal/symptom absent), 7 - 19 (mild depression), 20 - 34 (moderate depression), and > 34 (severe depression).The overall score ranges from 0 to 60 | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating; women of reproductive potential must have a negative urine pregnancy test (urine dipstick method)
Post-Partum state : defined as being within 2 months of delivery or miscarriage
Homicide risk as determined by clinical interview
Treatment with any medication known to specifically target the glutamate-NMDA receptor system (ie lamotrigine, acamprosate, memantine, riluzole or lithium)
Any known hypersensitivity or serious adverse effect associated with ketamine treatment.
Any clinically significant medical condition or therapy that would preclude treatment with ketamine, to include recent myocardial infarction or unstable angina
Medically unstable, including acute withdrawal from alcohol or benzodiazepines requiring the use of benzodiazepine treatment.
Any of the following DSM-IV diagnoses or categories:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl B McCullumsmith, MD PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Suicidal, Depression With Ketamine | 0.2 mg/kg IV ketamine administered as a one time dose in patients with suicidal ideatin and depression without substance use Ketamine |
| FG001 | Suicidal, Depression With Saline | comparable amount of placebo (saline) as would have been used with the Ketamine arm placebo |
| FG002 | Suicidal, Depression and Opioid Use With Ketamine | suicidal, depressed with opioid use, given 0.2 mg/kg ketamine one time dose IV infusion |
| FG003 | Suicidal, Depression With Opioid Use With Saline | suicidal, depression with opioid use, given saline IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Suicidal, Depression With Ketamine | suicidal and depressed, no substance use 0.2 mg/kg IV ketamine administered as a one time dose Ketamine |
| BG001 | Suicidal, Depression With Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Suicidality | Scales and questionnaires using the Beck Scale for Suicidal Ideation. The Beck Scale is a self-report questionnaire. The items on this scale identify the presence and severity of suicidal ideation. Beck Scale for Suicidal Ideation has 19 items,preceded by a 5 item screener. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide. | Posted | Mean | Standard Deviation | units on a scale | 2 hours |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Suicidal, Depression With Ketamine | Suicidal with depression and no substance use 0.2 mg/kg IV ketamine administered as a one time dose Ketamine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sedation | Nervous system disorders | Non-systematic Assessment |
short term followup small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheryl McCullumsmith | University of Cincinnati | 513-5588022 | cheryl.mccullumsmith@uc.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| placebo | Drug | saline infusion |
|
|
suicidal and depressed, no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm
placebo
| BG002 | Suicidal, Depression and Opioid Use With Ketamine | suicidal and depressed, opioid use 0.2 mg/kg IV ketamine administered as a one time dose Ketamine |
| BG003 | Suicidal, Depression and Opioid Use With Ketamine | suicidal and depressed,opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm placebo |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
comparable amount of placebo (saline) as would have been used with the Ketamine arm
placebo
| OG002 | Suicidal, Opioid Use With Ketamine | suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose |
| OG003 | Suicidal, Opioid Use With Saline | Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm |
|
|
| Secondary | Depression | Scales and Questionnaire using the MADRS (Montgomery-Asberg Depression Rating Scale) . This is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. the scale: 0 - 6 (normal/symptom absent), 7 - 19 (mild depression), 20 - 34 (moderate depression), and > 34 (severe depression).The overall score ranges from 0 to 60 | Posted | Mean | Standard Deviation | units on a scale | 2 hours |
|
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | Suicidal, Depression With Saline | Suicidal with depression and no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm placebo | 0 | 7 | 0 | 7 |
| EG002 | Suicidal, Depression and Opioid Use With Ketamine | Suicidal with depression and opioid use 0.2 mg/kg IV ketamine administered as a one time dose Ketamine | 0 | 2 | 0 | 2 |
| EG003 | Suicidal, Depression and Opioid With Saline | Suicidal with depression and opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm placebo | 0 | 2 | 0 | 2 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |