Clinical TrialMajor Depressive Disorder (MDD)KetamineCompleted

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.

Target Enrollment
14 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Open-label, single-group Phase I study in Emergency Department patients (n=14) testing a single IV sub-anaesthetic ketamine dose (0.2 mg/kg over 1–2 minutes) for rapid antidepressant effects and reduction in suicide ideation; patients monitored for 4 hours post-dose.

The published manuscript was later retracted after a Yale investigation found that the protocol-specified doses and the actual delivered doses of ketamine were misrepresented.

Study Protocol

Preparation

sessions

Dosing

1 sessions
240 min each

Integration

sessions

Study Arms & Interventions

Ketamine IV

experimental

Single sub-anaesthetic IV bolus of ketamine (0.2 mg/kg over 1–2 min) with 4 h monitoring.

Interventions

  • Ketamine0.2 mg/kg
    via IV• single dose

    0.2 mg/kg administered over 1–2 minutes; monitored for 4 h post-dose.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • adults (>18 years) 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

  • Exclusion Criteria:
  • psychosis, bipolar, or other significant physical or mental illness
  • pregnancy
  • non-voluntary status
  • urine drug screen positive for drugs of abuse

Study Details

Locations

Yale New Haven Hospital Emergency Department — New Haven, Connecticut, United States

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