RecruitingPhase 3NCT06752759

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

Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting: A Midazolam-controlled Randomized Controlled Trial

Sponsor

Theresa Jacob, PhD, MPH

Enrollment

40 participants

Start Date

Oct 16, 2024

Study Type

INTERVENTIONAL

Conditions

Midazolam Depressive Symptom Severe Depression Moderate Depression Ketamine Peripheral Nervous System Agents Central Nervous System Agents Neurotransmitter Agents Physiologic Effects of Drugs Sensory System Agents Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Hypnotics and Sedatives Anti-anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics Agent GABA Modulators GABA Agents

Summary

This is a double blind active placebo controlled clinical trial for individuals within an inpatient setting with moderate to severe depression. The purpose of this study is to assess if nebulized ketamine can reduce depressive symptoms.

Eligibility

Min Age: 18 YearsMax Age: 88 Years

Inclusion Criteria3

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 Criteria15

Adult patients with an allergy to ketamine
Adult patients with an allergy to Midazolam
Individuals with a history of mania/hypomania or diagnosis of 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 \> 150kg
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

Interventions

DRUGnebulized ketamine

The formulation of the study drug is administered via nebulizer in which the participants inhales the study drug. The dosage is calculated by body weight (1.5mg/kg).