Ketamine for Low Mood States in the ER

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-12-31

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.

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The manuscript (article) for this study has been retracted because Yale University conducted an investigation that determined that the description of the research was not accurate.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

Conditions

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Depression Suicide Ideation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ketamine

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.

Group Type EXPERIMENTAL

ketamine

Intervention Type DRUG

intravenous ketamine(0.2 mg/kg) over 1-2 minutes IV

Interventions

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ketamine

intravenous ketamine(0.2 mg/kg) over 1-2 minutes IV

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No