Nebulized Ketamine for Major Depressive Disorder

Nebulized Ketamine for the Treatment of Major Depressive Disorder

Recruiting Phase 3 Interventional Study
Severe 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
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 88
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Theresa Jacob, PhD, MPH · Other
Who this trial is looking for

This trial is looking for adults with moderate to severe depression to see if nebulized ketamine can help reduce their symptoms. Participants will be monitored during the trial.

Are You a Good Fit for This Trial?
Rules you out Bipolar disorderPsychotic disorderObsessive-compulsive disorderAntisocial personality disorderBorderline personality disorderPosttraumatic stress disorderAltered mental statusHypertension

You may be able to join if

  • I am 18 years or older
  • I have a score of 20 or higher on a depression scale
  • I have been diagnosed with moderate to severe Major Depressive Disorder

You may not be able to join if

  • I am allergic to Ketamine
  • I am allergic to Midazolam
  • I have a history of mania or bipolar disorder
  • I have had thoughts of harming myself or others recently
  • I have a past or current psychotic disorder
  • I have a substance use disorder in the last 3 months
  • I weigh more than 150 kg
  • I am pregnant or breastfeeding

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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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.

Trial Locations
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Eligibility 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 E…
Contacts

Jessica Poster, MD

718-283-8170

JPoster@maimo.org

CONTACT