Ketamine for Low Mood States in the ER

Study Overview
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Brief Summary
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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.

Detailed Description
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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 The manuscript (article) for this study has been retracted because Yale University conducted an investigation that determined that the description of the research was not accurate.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.

Official Title
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Low Dose Ketamine for Low Mood States: An Emergency Department Feasibility Study for Depressed Patients

Conditions
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Depression, Suicide Ideation

Intervention / Treatment
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* Drug: ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults (>18yrs) presenting to the Emergency department with symptoms of depression and/or suicide ideation (MADRS>30) with ability to give informed consent. medically stable Exclusion Criteria: psychosis, bipolar, or other significant physical or mental illness pregnancy non-voluntary status urine drug screen positive for drugs of abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>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. | Drug: ketamine<br>* intravenous ketamine(0.2 mg/kg) over 1-2 minutes IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, suicide ideation, emergency department, ketamine