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

Theresa Jacob, PhD, MPH

Status and phase

Enrolling

Phase 3

Conditions

Anesthetics Agent

Anti-Inflammatory Agents, Non-Steroidal

GABA Agents

Moderate Depression

Analgesics, Non-Narcotic

Midazolam

Sensory System Agents

GABA Modulators

Physiologic Effects of Drugs

Tranquilizing Agents

Psychotropic Drugs

Neurotransmitter Agents

Peripheral Nervous System Agents

Depressive Symptom

Central Nervous System Agents

Ketamine

Anti-anxiety Agents

Hypnotics and Sedatives

Severe Depression

Treatments

Drug: nebulized ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT06752759

2023-06-05-MMC

Details and patient eligibility

About

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.

Full description

The objective of this study is to evaluate the effect of ketamine formalized to be dispensed via inhalation, as an adjunct to concomitant medications and therapies on those with moderate to severe depression currently in an inpatient psychiatric unit. Investigators will examine the effects of nebulized ketamine on depressive symptoms.

This is a prospective double-blind placebo controlled study in which an active placebo, Midazolam, will be used. Participants will commit to either 4 visits or 5 visits depending on which treatment arm they are randomized into. All visits can be done remotely, however, days in which the participant will be dosed will have to be in person. During dosing days, the participant will be monitored for a minimum of two hours. Study participant's vitals will be collected at regular intervals during the observation period.

Adult psychiatry inpatients who are 18 years and older with a diagnosis of moderate to severe depression will be screened for enrollment by the study.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 88 years old

Volunteers

No Healthy Volunteers

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