Ketamine for Low Mood States in the ER

Yale University

Status and phase: Completed; Phase 1

Conditions: Suicide Ideation; Depression

Treatments: Drug: ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01209845

0909005766

Details and patient eligibility

About

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.

Full description

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The manuscript (article) for this study has been retracted because Yale University conducted an investigation that determined that the description of the research was not accurate.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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Ketamine

Experimental group

Description:

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.

Treatment:

Drug: ketamine