Ketamine for Low Mood States in the ER

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.

Intervention / Treatment

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

Condition or Disease

  • Depression
  • Suicide Ideation

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 14 (ACTUAL)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Apr 01, 2010
    Primary Completion: Dec 01, 2010 ACTUAL
    Completion Date: Dec 01, 2010 ACTUAL
    Study First Posted: Sep 27, 2010 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 19, 2020

    Sponsors / Collaborators

    Lead Sponsor: Yale University
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    New Haven, Connecticut, USA

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    The manuscript (article) for this study has been retracted because Yale University conducted an investigation that determined that the description of the research was not accurate.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

    Participant Groups

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

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

    Secondary Outcomes

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

    More Details

    NCT Number: NCT01209845
    Other IDs: 0909005766
    Study URL: https://clinicaltrials.gov/study/NCT01209845
    Last updated: Sep 29, 2023