Nebulized Ketamine for the Treatment of Major Depressive Disorder

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Theresa Jacob, PhD, MPH
Study ID
NCT06752759
Phase
PHASE3
Status
Recruiting
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Conditions

  • Analgesics, Non-Narcotic
  • Anesthetics Agent
  • Anti-Inflammatory Agents, Non-Steroidal
  • Anti-anxiety Agents
  • Central Nervous System Agents
  • Depressive Symptom
  • Hypnotics and Sedatives
  • Ketamine
  • Midazolam
  • Moderate Depression
  • Neurotransmitter Agents
  • Peripheral Nervous System Agents
  • Physiologic Effects of Drugs
  • Psychotropic Drugs
  • Sensory System Agents
  • Severe Depression
  • Tranquilizing Agents

Eligibility Criteria

Sex
ALL
Age
18 Years - 88 Years
Healthy Volunteers
Not accepted

Interventions

  • nebulized ketamine — DRUG
    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 — DRUG
    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).

Study Details

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.

Key Dates

Start date
Oct 16, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Maimonides Medical CenterBrooklynNew York11219
Mayank Kumar, PhD
[email protected]
718-283-8170
Hasan Mustafic, BA
[email protected]
718-283-8170
Jessica Poster, MD (PRINCIPAL_INVESTIGATOR)
Simran Ailani, MBBS (PRINCIPAL_INVESTIGATOR)
Theresa Jacob, PhD, MPH (SUB_INVESTIGATOR)

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By research site
Maimonides Medical Center· Brooklyn, NY

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