Suicidal Ideation
Conditions
Keywords
ketamine, suicidal ideation, length of stay
Brief summary
This study will evaluate the effect of ketamine on the treatment of patients hospitalized with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein. The other half will receive a placebo. Because we think that ketamine will improve depression and suicidal thoughts, we expect that patients who receive ketamine will require less time in the hospital than patients who receive placebo.
Detailed description
Patients admitted to UMMC's psychiatry inpatient unit with suicidal thoughts will be given the opportunity to participate in the study. Those patients who consent to participate, after being informed about the study and its risks, will be randomized to receive an IV infusion of either saline or ketamine 0.5 mg/kg. The infusion will be given within 24 hours of arriving on the psychiatry inpatient unit. We will record the dates and times that the patient was admitted to and discharged from the psychiatric inpatient unit. At completion of the study, we will compare the average length of stay, defined as date and time of discharge minus date of time of admission, of the group that received ketamine to the average length of stay of the group that received placebo.
Interventions
DRUGKetamine
IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.
DRUGNormal Saline
IV infusion of 100 ml of normal saline over 45 minutes.
Sponsors
Allen Richert
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women between the ages of 18 and 64 2. Patients admitted to the University of Mississippi Medical Center inpatient psychiatry service with suicidal ideations
Exclusion criteria
1. Lifetime history of schizophrenia or other primary psychotic disorder 2. Current psychotic or manic symptoms 3. Substance use disorder within one month of admission 4. Positive urine toxicology at admission 5. Any lifetime abuse of ketamine or phencyclidine 6. Systolic BP \>180 mmHg or diastolic BP \>110 mmHg 7. Any patient who has eaten food within 8 hours prior to receiving the ketamine infusion or who has drank clear liquids within 2 hours prior to receiving the infusion 8. Known central nervous system (CNS) mass 9. CNS abnormalities 10. Hydrocephalus 11. Glaucoma 12. Acute globe injury 13. Porphyria 14. Untreated thyroid disease 15. Known coronary artery disease with poor functional capacity 16. Pregnancy 17. Currently breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inpatient Hospital Length of Stay | The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study. | We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine Infusion Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.
Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes. | 3 |
| Normal Saline Infusion Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.
Normal Saline: IV infusion of 100 ml of normal saline over 45 minutes. | 1 |
| Total | 4 |
Baseline characteristics
| Characteristic | Normal Saline Infusion | Total | Ketamine Infusion |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 3 Participants |
| Age, Continuous | 36 years | 44.75 years | 47.67 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 1 participants | 4 participants | 3 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 1 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
Primary
Inpatient Hospital Length of Stay
We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.
Time frame: The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketamine Infusion | Inpatient Hospital Length of Stay | 130.75 hours |
| Normal Saline Infusion | Inpatient Hospital Length of Stay | 81.97 hours |