Clinical TrialMajor Depressive Disorder (MDD)KetamineUnknown status

Ketamine for Mood Disorders With Suicidal Ideation

This study will explore whether the use of a medication, ketamine, can help patients who come to the ER with thoughts of suicide by improving their mood and reducing thoughts of suicide.

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

Detailed Description

This prospective open-label feasibility pilot study enrolled 20 participants presenting to the emergency department with active suicidal ideation to receive a single IV ketamine infusion (0.5 mg/kg over 40 minutes).

Primary aims were feasibility (recruitment, tolerability, acceptability) and exploratory assessment of mood and suicidal ideation at baseline, 2 and 6 hours post-infusion, and daily while awaiting inpatient disposition.

Patients were monitored by ED staff for adverse events; data collected included surveys of suicidal thinking and mood, demographics, current medications, and medical history.

Study Protocol

Preparation

0 sessions

Dosing

1 sessions
40 min each

Integration

0 sessions

Study Arms & Interventions

Ketamine

experimental

Single-group open-label infusion of intravenous ketamine 0.5 mg/kg over 40 minutes for patients with active suicidal ideation in the ED.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Infused over 40 minutes; dose based on weight.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • English speaking
  • between 18 and 65 years of age
  • have active suicidal ideation as determined by psychiatry staff
  • are being admitted to psychiatry under voluntary certification and are able to provide informed consent.

Exclusion Criteria

  • Exclusion Criteria:
  • have been previously enrolled in the trial
  • are pregnant or breastfeeding; have a known or suspected allergy to ketamine; have used ketamine within 24h of presentation
  • require antipsychotics (prescription or PRN by ED staff) or ED administration of other mood-altering medications for the management of acute agitation
  • have known renal or liver failure; have neurologic, respiratory, or hemodynamic compromise as determined by the treating ED physician
  • have history of stroke or cardiac disease (prior MI, cardiac stents or bypass surgery); or are incarcerated

Study Details

Locations

The Miriam Hospital — Providence, Rhode Island, United States

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