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Completed

NCT Number: NCT01209845

Ketamine for Low Mood States in the ER

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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Key information

Conditions

Depression Behavior Behavioral Symptoms Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Suicide Ideation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale New Haven Hospital Emergency Department

New Haven, Connecticut, 06519, United States

About this study

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The manuscript (article) for this study has been retracted because Yale University conducted an investigation that determined that the description of the research was not accurate.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

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

Primary outcomes

  1. Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: 40, 80, 120, 240 minutes after administration of drug

    The MADRS measures mood (depression) and item 10 measures suicide ideation.

Secondary outcomes

  1. recruitment success and retention of subjects in the ER

    Time frame: initial recruitment of eligible subjects in the ER and for two weeks after administration of drug

    All patient subjects are admitted and we will follow them in the hospital and for 2 weeks after hospital discharge.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 27, 2010
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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