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Staffing and space deficiencies prevented completion of the study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine infusion | Experimental | Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes. |
|
| Normal Saline infusion | Placebo Comparator | Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | IV infusion of ketamine 0.5 mg/kg administered over 45 minutes. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allen C Richert, MD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Normal Saline Infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | Posted | Mean | Full Range | hours | 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 recorded adverse events that occurred during the infusion and for 30 minutes after the infusion.
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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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
The small number of subjects (i.e., only 4) recruited prior to the premature termination of this study prevents one from drawing meaningful conclusions from this data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allen Richert, MD | University of Mississippi Medical Center | (601) 984-4820 | arichert@umc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2017 | Apr 16, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2017 | Apr 16, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Normal Saline |
| Drug |
IV infusion of 100 ml of normal saline over 45 minutes. |
|
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
|
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| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |