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

Launched by THERESA JACOB, PHD, MPH · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of nebulized ketamine to help reduce symptoms of moderate to severe depression in patients who are staying in a hospital. The researchers want to find out if this method of delivering ketamine can be an effective treatment for people who struggle with depression. To participate, individuals must be at least 18 years old, have a diagnosis of major depressive disorder, and show significant levels of depression based on a specific rating scale.

Eligible participants will be closely monitored throughout the trial and will receive either the nebulized ketamine or a placebo (a substance with no active medication) without knowing which one they are getting. This is to ensure that the results are accurate and unbiased. It's important to note that individuals with certain medical conditions or those taking specific medications will not be able to participate, as their safety is a top priority. If you or a family member are considering this study, it could be a chance to explore a new treatment option for depression in a supportive hospital environment.

Gender

ALL

Eligibility 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:
• • 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