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Ketamine for Low Mood States in the ER

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01209845
Enrollment
14
Registered
2010-09-27
Start date
2010-04-30
Completion date
2010-12-31
Last updated
2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Suicide Ideation

Keywords

depression, suicide ideation, emergency department, ketamine

Brief summary

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

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 The manuscript (article) for this study has been retracted because Yale University conducted an investigation that determined that the description of the research was not accurate.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

Interventions

DRUGketamine

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

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Montgomery Asberg Depression Rating Scale (MADRS)40, 80, 120, 240 minutes after administration of drugThe MADRS measures mood (depression) and item 10 measures suicide ideation.

Secondary

MeasureTime frameDescription
recruitment success and retention of subjects in the ERinitial recruitment of eligible subjects in the ER and for two weeks after administration of drugAll patient subjects are admitted and we will follow them in the hospital and for 2 weeks after hospital discharge.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026