Recruiting
Phase 3

Ketamine

Sponsor:

Theresa Jacob, PhD, MPH

Code:

NCT06752759

Conditions

Severe Depression

Moderate Depression

Ketamine

Midazolam

Peripheral Nervous System Agents

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

nebulized ketamine

nebulized midazolam

Study Details

Brief summary:

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.

Conditions

Severe Depression

Moderate Depression

Ketamine

Midazolam

Peripheral Nervous System Agents

Study ID

NCT06752759

Start date

Oct 16, 2024

Status verified date

Apr, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Nebulized Midazolam

Midazolam used as active comparator. Dosage calculated by body weight at 0.03mg/kg

experimental: Nebulized Ketamine

Ketamine dosage calculated by body weight at 1.5mg/kg

Interventions

nebulized 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).

nebulized midazolam

The formulation of the active comparator drug is administered via nebulizer in which the participant inhales the study drug. The dosage is calculated by body weight (0.03mg/kg).

Primary outcome measure

  • Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 8-10 days ]

Central Contacts and Locations

Central contacts

Jessica Poster, MD

718-283-8170JPoster@maimo.org

Locations

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Mayank Kumar, PhD

718-283-8170Maykumar@maimo.org

Hasan Mustafic, BA

718-283-8170HMustafic@maimo.org

Principal Investigator:

Jessica Poster, MD

More Information

Sponsor

Theresa Jacob, PhD, MPH

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • Maimonides Medical Center
  • Psychiatry
  • Ketamine
  • Midazolam
  • Peripheral Nervous System Agents
  • Sensory System Agents
  • Anesthetics, Dissociative
  • Nebulized Medications for depression
  • GABA Agents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Theresa Jacob, PhD, MPH on 2026-04-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.