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The investigators hope to see if a commonly used drug such as ketamine could help depressed ER patients feel better and improve their mood quickly.
Rapid-onset antidepressants could have important clinical impact if their benefits extended to Emergency Department (ED) patients. We hope to explore the preliminary feasibility, tolerability and efficacy of single-dose, intravenous (IV) ketamine in depressed ED patients who presented with suicide ideation (SI).
The manuscript (article) for this study has been retracted because Yale University conducted an investigation that determined that the description of the research was not accurate. The article misrepresents both the protocol-specified doses and the actual delivered doses of ketamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Experimental | Patients were administered a single sub-anaesthetic i.v. bolus of ketamine (0.2 mg/kg over 1-2 min) in the ED, with continuous monitoring of vital signs, adverse events and psychotomimetic side-effects for 4 h post-administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine | Drug | intravenous ketamine(0.2 mg/kg) over 1-2 minutes IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) | The MADRS measures mood (depression) and item 10 measures suicide ideation. | 40, 80, 120, 240 minutes after administration of drug |
| Measure | Description | Time Frame |
|---|---|---|
| recruitment success and retention of subjects in the ER | All patient subjects are admitted and we will follow them in the hospital and for 2 weeks after hospital discharge. | initial recruitment of eligible subjects in the ER and for two weeks after administration of drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory L Larkin, MD | Yale University School of Medicine, Department of Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital Emergency Department | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28637184 | Result | Larkin GL, Beautrais AL. A Preliminary Naturalistic Study of Low-Dose Ketamine for Depression and Suicide Ideation in the Emergency Department. Int J Neuropsychopharmacol. 2017 Jul 1;20(7):611. doi: 10.1093/ijnp/pyx035. No abstract available. | |
| 21557878 | Result | Larkin GL, Beautrais AL. A preliminary naturalistic study of low-dose ketamine for depression and suicide ideation in the emergency department. Int J Neuropsychopharmacol. 2011 Sep;14(8):1127-31. doi: 10.1017/S1461145711000629. Epub 2011 May 5. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |