Nebulized Ketamine for the Treatment of Major Depressive Disorder

ConditionsSevere Depression Moderate Depression Ketamine Midazolam 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 Depressive Symptom Hypnotics and Sedatives Anti-anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics Agent

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-88

SponsorTheresa Jacob, PhD, MPH

About this trial

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

Eligibility criteria

Qualifiers

All individuals 18 years and older with a Montgomery-Asberg Depression Rating Scale score (MADRS) ≥ 20

Must have a diagnosis of moderate to severe Major Depressive Disorder (MDD)

Structured Clinical Interview for DSM-5 (SCID-5) will be performed to confirm MDD diagnosis

Disqualifiers

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

Trial design

Treatments tested in this trial

nebulized ketamine
nebulized midazolam

Treatment groups

40 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Theresa Jacob, PhD, MPH

Lead sponsor

Maimonides Medical Center

Sponsor institution

Source ClinicalTrials.gov