Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboRecruiting

Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting

This triple-blind, active placebo-controlled crossover trial (n=40) will assess nebulized ketamine (1.5 mg/kg; ~105 mg/70 kg) versus active placebo midazolam (0.03 mg/kg; ~2.1 mg/70 kg) for reduction of depressive symptoms in adult psychiatric inpatients with moderate to severe MDD.

Target Enrollment
40 participants
Study Type
Phase III interventional
Design
Randomized, triple Blind

Detailed Description

Randomized, triple-blind crossover study in adult inpatient psychiatry units comparing a single nebulized dose of ketamine (1.5 mg/kg) with an active midazolam placebo (0.03 mg/kg); participants complete 4 or 5 visits depending on randomised arm.

Dosing visits are in-person with a minimum 2-hour post-dose observation including regular vital sign monitoring; the intervention is administered via nebuliser as an adjunct to concomitant medications and therapies.

Study Protocol

Preparation

sessions

Dosing

2 sessions
120 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Nebulized Ketamine

experimental

Nebulized ketamine dosed by body weight in a crossover design.

Interventions

  • Ketamine1.5 mg/kg
    via Inhalation• single dose• 1 doses total

    Nebulized formulation (Ketalar); dose 1.5 mg/kg (~105 mg/70 kg).

Nebulized Midazolam

active comparator

Active placebo comparator using midazolam dosed by body weight.

Interventions

  • Placebo0.03 mg/kg
    via Inhalation• single dose• 1 doses total

    Midazolam active placebo 0.03 mg/kg (~2.1 mg/70 kg).

Participants

Ages
18 – 88
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • All individuals 18 years and older within the Institution's inpatient Psychiatry Unit with a Montgomery-Asberg Depression Rating Scale score ≥ 20
  • Must have a diagnosis of moderate to severe Major Depressive Disorder
  • Structured Clinical Interview for DSM-5 (SCID-5) will be performed to confirm MDD diagnosis

Exclusion Criteria

  • Exclusion Criteria:
  • Adult patients with an allergy to ketamine
  • Adult patients with an allergy to midazolam
  • Individuals with a history of mania/hypomania or diagnosis of bipolar disorder
  • Patients on lithium and/or lamotrigine therapy
  • Recent or current homicidal ideation with an intent to act
  • MDD with psychotic features or current or past diagnosis of a psychotic disorder
  • No substance use disorder in the preceding 3 months except nicotine or caffeine or a positive urine screen for substances (except cannabis)
  • Diagnosis of obsessive-compulsive disorder, antisocial personality disorder, borderline personality disorder, posttraumatic stress disorder, intellectual disability, altered mental status
  • Pregnant or breastfeeding patients
  • Patients on > 2 medications for hypertension
  • Patients with uncontrolled hypertension (BP >140 mm Hg systolic and/or >90 mm Hg diastolic on two separate readings at the time of screening)
  • Body weight of > 150 kg
  • Patients with history of congestive cardiac failure
  • Day of presentation, patients with unstable vital signs (systolic blood pressure <90 or >160 mm Hg, pulse rate <50 or >150 beats/min, and respiration rate <10 or >30 breaths/min)
  • Consumption of opioids within 24 hours of drug administration
  • Acutely intoxicated patients will also be excluded

Study Details

Locations

Maimonides Medical Center — Brooklyn, New York, United States

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