Nebulized ketamine treatment for major depression in hospitalized patients
Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting: A Midazolam-controlled Randomized Controlled Trial
This study is testing if breathing in ketamine can help people with moderate to severe depression feel better while they are in the hospital.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 88 Years |
| Sex | All |
| Sponsor | Maimonides Medical Center Academic / other |
| Locations | 1 site (Brooklyn, New York) |
| Trial ID | NCT06752759 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of nebulized ketamine as a treatment for individuals with moderate to severe depression who are currently hospitalized. It is a double-blind, placebo-controlled study where participants will receive either nebulized ketamine or an active placebo, Midazolam, during their inpatient stay. Participants will undergo a series of visits, with dosing days requiring in-person attendance for monitoring. The study aims to assess the reduction of depressive symptoms through this innovative delivery method of ketamine.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with moderate to severe Major Depressive Disorder currently admitted to a psychiatric unit.
Not a fit: Patients with a history of bipolar disorder, psychotic disorders, or those allergic to ketamine or Midazolam may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a rapid and effective option for alleviating severe depressive symptoms in hospitalized patients.
How similar studies have performed: Other studies have shown promising results with ketamine for depression, but the specific use of nebulized ketamine is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 \> 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
Where this trial is running
Brooklyn, New York
- Maimonides Medical Center — Brooklyn, New York, United States (Recruiting)
Study contacts
- Study coordinator: Jessica Poster, MD
- Email: JPoster@maimo.org
- Phone: 718-283-8170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.