Nebulized Ketamine for the Treatment of Major Depressive Disorder
Recruiting
Phase 3Interventional Study
Severe DepressionModerate DepressionKetamineMidazolamPeripheral Nervous System AgentsCentral Nervous System AgentsNeurotransmitter AgentsPhysiologic Effects of DrugsSensory System AgentsAnalgesics, Non-NarcoticAnti-Inflammatory Agents, Non-SteroidalDepressive SymptomHypnotics and SedativesAnti-anxiety AgentsTranquilizing AgentsPsychotropic DrugsAnesthetics 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.
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?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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
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