Depression, Suicidal Ideation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGKetamine
single dose IV 0.2 mg/kg ketamine
DRUGplacebo
saline infusion
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age : 19-64 2. Significant suicidality score on the Columbia Suicide Severity Rating Scale (C-SSRS) 3. Willing and able to provide informed consent. 4. Individuals with current substance abuse are allowed
Exclusion criteria
1. Pregnant or lactating; women of reproductive potential must have a negative urine pregnancy test (urine dipstick method) 2. Post-Partum state : defined as being within 2 months of delivery or miscarriage 3. Homicide risk as determined by clinical interview 4. Treatment with any medication known to specifically target the glutamate-NMDA receptor system (ie lamotrigine, acamprosate, memantine, riluzole or lithium) 5. Any known hypersensitivity or serious adverse effect associated with ketamine treatment. 6. Any clinically significant medical condition or therapy that would preclude treatment with ketamine, to include recent myocardial infarction or unstable angina 7. Medically unstable, including acute withdrawal from alcohol or benzodiazepines requiring the use of benzodiazepine treatment. 8. Any of the following DSM-IV diagnoses or categories: * Any current psychosis or history of a non-mood psychotic disorder (e.g., schizophrenia) * Currently in a manic or mixed episode * Current use (defined by urine dipstick test) or abuse of hallucinogenic drugs (except marijuana) such as phencyclidine * Any dissociative disorder * Any pervasive developmental disorder (e.g., autism) * A cognitive disorder (e.g., Alzheimer's Disease) * Cluster A personality disorder (e.g., schizoid or schizotypal); note that cluster B and C personality disorders may be included * Any eating disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suicidality | 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 2 hours | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Suicidal, Depression With Ketamine suicidal and depressed, no substance use 0.2 mg/kg IV ketamine administered as a one time dose
Ketamine | 7 |
| Suicidal, Depression With Saline suicidal and depressed, no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm
placebo | 7 |
| 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 | 2 |
| 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 | 2 |
| Total | 18 |
Baseline characteristics
| Characteristic | Suicidal, Depression With Ketamine | Suicidal, Depression With Saline | Suicidal, Depression and Opioid Use With Ketamine | Total |
|---|---|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 10 | 37 years STANDARD_DEVIATION 11 | 31 years STANDARD_DEVIATION 4 | 35 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 7 participants | 7 participants | 2 participants | 18 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 0 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 2 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 7 | 0 / 7 | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 2 | 0 / 2 |
Outcome results
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.
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suicidal, Depression With Ketamine | Suicidality | 7.3 units on a scale | Standard Deviation 11.4 |
| Suicidal, Depression With Saline | Suicidality | 21.5 units on a scale | Standard Deviation 14.7 |
| Suicidal, Opioid Use With Ketamine | Suicidality | 18.0 units on a scale | Standard Deviation 25.5 |
| Suicidal, Opioid Use With Saline | Suicidality | 0 units on a scale | Standard Deviation 0 |
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
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suicidal, Depression With Ketamine | Depression | 43.9 units on a scale | Standard Deviation 26 |
| Suicidal, Depression With Saline | Depression | 59.4 units on a scale | Standard Deviation 17.2 |
| Suicidal, Opioid Use With Ketamine | Depression | 22.5 units on a scale | Standard Deviation 17.7 |
| Suicidal, Opioid Use With Saline | Depression | 12.5 units on a scale | Standard Deviation 3.5 |