Severe DepressionPhase 3NCT06752759

Nebulized Ketamine for the Treatment of Major Depressive Disorder

A Phase 3 study testing nebulized ketamine and nebulized midazolam in people with Severe Depression and Moderate Depression, run by Theresa Jacob, PhD, MPH at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 88 years
Conditions the study is for: Severe Depression, Moderate Depression, Ketamine
What is being tested?: nebulized ketamine and nebulized midazolam
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 16 Oct 2024to 30 Sep 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 88 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jessica Poster, MD contact

718-283-8170

JPoster@maimo.org

United States1 site, 1 recruiting

Maimonides Medical Center
Brooklyn, New York, 11219
Mayank Kumar, PhD, 718-283-8170, Maykumar@maimo.org
Hasan Mustafic, BA, 718-283-8170, HMustafic@maimo.org
Recruiting

Other trials in United States

About this study

Official title: Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting: A Midazolam-controlled Randomized Controlled Trial

Read the detailed description

The objective of this study is to evaluate the effect of ketamine formalized to be dispensed via inhalation, as an adjunct to concomitant medications and therapies on those with moderate to severe depression currently in an inpatient psychiatric unit. Investigators will examine the effects of nebulized ketamine on depressive symptoms.

This is a prospective double-blind placebo controlled study in which an active placebo, Midazolam, will be used. Participants will commit to either 4 visits or 5 visits depending on which treatment arm they are randomized into. All visits can be done remotely, however, days in which the participant will be dosed will have to be in person. During dosing days, the participant will be monitored for a minimum of two hours. Study participant's vitals will be collected at regular intervals during the observation period.

Adult psychiatry inpatients who are 18 years and older with a diagnosis of moderate to severe depression will be screened for enrollment by the study.

Conditions: Severe Depression, Moderate Depression, Ketamine, Midazolam, Peripheral Nervous System Agents, Central Nervous System Agents
Being tested: nebulized ketamine, nebulized midazolam
Keywords: Maimonides Medical Center, Psychiatry, Ketamine, Midazolam, Peripheral Nervous System Agents, Sensory System Agents, Anesthetics, Dissociative, Nebulized Medications for depression, GABA Agents
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nebulized ketamineDrug
Also called Ketalar
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 midazolamDrug
Also called 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).

Study groups in NCT06752759
Study group	Role	What they receive
Nebulized Midazolam	Active comparator	Midazolam used as active comparator. Dosage calculated by body weight at 0.03mg/kg Receives: Drug: nebulized midazolam
Nebulized Ketamine	Experimental	Ketamine dosage calculated by body weight at 1.5mg/kg Receives: Drug: nebulized ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS)
Montgomery-Asberg Depression Rating Scale (MADRS) has a range from 0 to 60, where the lower score indicates the better health status. Change in mean total Montgomery Asberg Depression Rating Scale (MADRS) score from the baseline (pre-dose day 1 ), Day 2 and last day of assessments (Day 8 or Day 10)
Measured: 8-10 days

Secondary outcomes (6)

A change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) from the baseline (pre-dose on day 1) and 2 hours post-medication administration
Montgomery-Asberg Depression Rating Scale (MADRS) has a range from 0 to 60, where the lower score indicates the better health status. Change in mean total MADRS prior to dose administration on Day 1, 2 hours after dose administration for each day.
Measured: 8-10 days
Change in Beck Scale for Suicide Ideation
Beck Scale for Suicide Ideation (SSI) has a range from 0 to 42, where the lower score indicates the better health status. SSI score of ≥4, response which would be defined as SSI ≥50% below baseline - 2 hours post medication administration and remission defined as SSI score of ≥50% and lower than 4 - 24 hrs after medication administration of follow-up
Measured: 24 hours
Clinician-Administered Dissociative States Scale (CADSS)
Measurement of dissociative symptoms. Clinician Administered Dissociative States Scale (CADSS) comprises 23 subjective items, each on a 5 point scale, a "0" represents absence of any adverse events and "4" represents a severely bothersome side effect. A total score ranges from 0-92, a lower score indicates a better health status.
Measured: 8-10 days
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA)
Overall side effects as measured by the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). SERSDA has 9 items, each graded on a five point scale, with "0" representing the absence of any adverse effects and "4" representing a severely bothersome side effect.
Measured: 8-10 days
Maximal sedative effects using Modified Observer's Assessment of Alertness and Sedation ( MOAA/S)
Modified Observer's Alertness/Sedation Scale ( MOAA/S) uses a 6 point scale. A "0" indicates failure to respond to painful stimulus, "5" represents fully alert. .
Measured: 8-10 days
Richmond Agitation-Sedation Scale (RASS)
Measurement of participant's consciousness with a rating ranging from +4 to -5. +4 represents "combative", +3 represents "Very agitated", +2 represents "Agitated" , +1 represents restless, 0 represents "Alert and calm", -1 represents "Drowsy", -2 represents "Light sedation", -3 represents "Moderate sedation", -4 represents "Deep sedation", and -5 represents "Unarousable".
Measured: 8-10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 202430 Sep 2027

First posted31 Dec 2024
Study start16 Oct 2024
Primary completion30 Sep 2027 (estimated)
Study completion30 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Severe DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06752759
Sponsor's protocol ID: 2023-06-05-MMC
Status last verified: Apr 2026
First submitted: 23 Dec 2024
Last updated: 24 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Andrade C. Ketamine for Depression, 1: Clinical Summary of Issues Related to Efficacy, Adverse Effects, and Mechanism of Action. J Clin Psychiatry. 2017 Apr;78(4):e415-e419. doi: 10.4088/JCP.17f11567.
PubMed 28448702
Dove D, Fassassi C, Davis A, Drapkin J, Butt M, Hossain R, Kabariti S, Likourezos A, Gohel A, Favale P, Silver M, Marshall J, Motov S. Comparison of Nebulized Ketamine at Three Different Dosing Regimens for Treating Painful Conditions in the Emergency Department: A Prospective, Randomized, Double-Blind Clinical Trial. Ann Emerg Med. 2021 Dec;78(6):779-787. doi: 10.1016/j.annemergmed.2021.04.031. Epub 2021 Jul 3.
PubMed 34226073
Jonkman K, Dahan A, van de Donk T, Aarts L, Niesters M, van Velzen M. Ketamine for pain. F1000Res. 2017 Sep 20;6:F1000 Faculty Rev-1711. doi: 10.12688/f1000research.11372.1. eCollection 2017.
PubMed 28979762
Wilkinson ST, Farmer C, Ballard ED, Mathew SJ, Grunebaum MF, Murrough JW, Sos P, Wang G, Gueorguieva R, Zarate CA Jr. Impact of midazolam vs. saline on effect size estimates in controlled trials of ketamine as a rapid-acting antidepressant. Neuropsychopharmacology. 2019 Jun;44(7):1233-1238. doi: 10.1038/s41386-019-0317-8. Epub 2019 Jan 17.
PubMed 30653192
Drapkin J, Masoudi A, Butt M, Hossain R, Likourezos A, Motov S. Administration of Nebulized Ketamine for Managing Acute Pain in the Emergency Department: A Case Series. Clin Pract Cases Emerg Med. 2020 Jan 2;4(1):16-20. doi: 10.5811/cpcem.2019.10.44582. eCollection 2020 Feb.
PubMed 32064416
Gao M, Rejaei D, Liu H. Ketamine use in current clinical practice. Acta Pharmacol Sin. 2016 Jul;37(7):865-72. doi: 10.1038/aps.2016.5. Epub 2016 Mar 28.
PubMed 27018176
McIntyre RS, Rosenblat JD, Nemeroff CB, Sanacora G, Murrough JW, Berk M, Brietzke E, Dodd S, Gorwood P, Ho R, Iosifescu DV, Lopez Jaramillo C, Kasper S, Kratiuk K, Lee JG, Lee Y, Lui LMW, Mansur RB, Papakostas GI, Subramaniapillai M, Thase M, Vieta E, Young AH, Zarate CA Jr, Stahl S. Synthesizing the Evidence for Ketamine and Esketamine in Treatment-Resistant Depression: An International Expert Opinion on the Available Evidence and Implementation. Am J Psychiatry. 2021 May 1;178(5):383-399. doi: 10.1176/appi.ajp.2020.20081251. Epub 2021 Mar 17.
PubMed 33726522
Yavi M, Lee H, Henter ID, Park LT, Zarate CA Jr. Ketamine treatment for depression: a review. Discov Ment Health. 2022;2(1):9. doi: 10.1007/s44192-022-00012-3. Epub 2022 Apr 15.
PubMed 35509843
Kohtala S. Ketamine-50 years in use: from anesthesia to rapid antidepressant effects and neurobiological mechanisms. Pharmacol Rep. 2021 Apr;73(2):323-345. doi: 10.1007/s43440-021-00232-4. Epub 2021 Feb 20.
PubMed 33609274
Park M, Niciu MJ, Zarate CA Jr. Novel Glutamatergic Treatments for Severe Mood Disorders. Curr Behav Neurosci Rep. 2015 Dec;2(4):198-208. doi: 10.1007/s40473-015-0050-5. Epub 2015 Oct 9.
PubMed 26824031
Murrough JW, Iosifescu DV, Chang LC, Al Jurdi RK, Green CE, Perez AM, Iqbal S, Pillemer S, Foulkes A, Shah A, Charney DS, Mathew SJ. Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial. Am J Psychiatry. 2013 Oct;170(10):1134-42. doi: 10.1176/appi.ajp.2013.13030392.
PubMed 23982301
Witkin JM, Martin AE, Golani LK, Xu NZ, Smith JL. Rapid-acting antidepressants. Adv Pharmacol. 2019;86:47-96. doi: 10.1016/bs.apha.2019.03.002. Epub 2019 Apr 24.
PubMed 31378256
Henter ID, Park LT, Zarate CA Jr. Novel Glutamatergic Modulators for the Treatment of Mood Disorders: Current Status. CNS Drugs. 2021 May;35(5):527-543. doi: 10.1007/s40263-021-00816-x. Epub 2021 Apr 26.
PubMed 33904154
Holma KM, Melartin TK, Haukka J, Holma IA, Sokero TP, Isometsa ET. Incidence and predictors of suicide attempts in DSM-IV major depressive disorder: a five-year prospective study. Am J Psychiatry. 2010 Jul;167(7):801-8. doi: 10.1176/appi.ajp.2010.09050627. Epub 2010 May 17.
PubMed 20478879
Grunebaum MF, Galfalvy HC, Choo TH, Keilp JG, Moitra VK, Parris MS, Marver JE, Burke AK, Milak MS, Sublette ME, Oquendo MA, Mann JJ. Ketamine for Rapid Reduction of Suicidal Thoughts in Major Depression: A Midazolam-Controlled Randomized Clinical Trial. Am J Psychiatry. 2018 Apr 1;175(4):327-335. doi: 10.1176/appi.ajp.2017.17060647. Epub 2017 Dec 5.
PubMed 29202655

Interested in taking part?

Jessica Poster, MD

718-283-8170

JPoster@maimo.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Severe Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting: A Midazolam-controlled Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06752759
Acronym / sponsor ID: 2023-06-05-MMC
Conditions: Severe Depression, Moderate Depression, Ketamine, Midazolam, Peripheral Nervous System Agents, Central Nervous System Agents
Keywords: Maimonides Medical Center, Psychiatry, Ketamine, Midazolam, Peripheral Nervous System Agents, Sensory System Agents, Anesthetics, Dissociative, Nebulized Medications for depression
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 40 participants (estimated)
Lead sponsor: Theresa Jacob, PhD, MPHUniversity, hospital or other
Study start: 16 Oct 2024 (actual)
Primary completion: 30 Sep 2027 (estimated)
Study completion: 30 Sep 2027 (estimated)
First posted: 31 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Adult psychiatry inpatients who are 18 years and older with a diagnosis of moderate to severe depression will be screened for enrollment by the study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Nebulized Midazolam	Active comparator	Drug: nebulized midazolamMidazolam used as active comparator. Dosage calculated by body weight at 0.03mg/kg
Nebulized Ketamine	Experimental	Drug: nebulized ketamineKetamine dosage calculated by body weight at 1.5mg/kg

Who may qualify

Ages: 18 to 88 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nebulized ketamineAlso: KetalarThe 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).	Drug	Nebulized Ketamine
nebulized midazolamAlso: MidazolamThe 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).	Drug	Nebulized Midazolam

Primary outcome

Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 8-10 days
Montgomery-Asberg Depression Rating Scale (MADRS) has a range from 0 to 60, where the lower score indicates the better health status. Change in mean total Montgomery Asberg Depression Rating Scale (MADRS) score from the baseline (pre-dose day 1 ), Day 2 and last day of assessments (Day 8 or Day 10)

6 secondary outcomes

A change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) from the baseline (pre-dose on day 1) and 2 hours post-medication administration
Time frame: 8-10 days
Change in Beck Scale for Suicide Ideation
Time frame: 24 hours
Clinician-Administered Dissociative States Scale (CADSS)
Time frame: 8-10 days
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA)
Time frame: 8-10 days
Maximal sedative effects using Modified Observer's Assessment of Alertness and Sedation ( MOAA/S)
Time frame: 8-10 days
Richmond Agitation-Sedation Scale (RASS)
Time frame: 8-10 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Background: PubMed 28448702Andrade C. Ketamine for Depression, 1: Clinical Summary of Issues Related to Efficacy, Adverse Effects, and Mechanism of Action. J Clin Psychiatry. 2017 Apr;78(4):e415-e419. doi: 10.4088/JCP.17f11567.
Background: PubMed 34226073Dove D, Fassassi C, Davis A, Drapkin J, Butt M, Hossain R, Kabariti S, Likourezos A, Gohel A, Favale P, Silver M, Marshall J, Motov S. Comparison of Nebulized Ketamine at Three Different Dosing Regimens for Treating Painful Conditions in the Emergency Department: A Prospective, Randomized, Double-Blind Clinical Trial. Ann Emerg Med. 2021 Dec;78(6):779-787. doi: 10.1016/j.annemergmed.2021.04.031. Epub 2021 Jul 3.
Background: PubMed 28979762Jonkman K, Dahan A, van de Donk T, Aarts L, Niesters M, van Velzen M. Ketamine for pain. F1000Res. 2017 Sep 20;6:F1000 Faculty Rev-1711. doi: 10.12688/f1000research.11372.1. eCollection 2017.
Background: PubMed 30653192Wilkinson ST, Farmer C, Ballard ED, Mathew SJ, Grunebaum MF, Murrough JW, Sos P, Wang G, Gueorguieva R, Zarate CA Jr. Impact of midazolam vs. saline on effect size estimates in controlled trials of ketamine as a rapid-acting antidepressant. Neuropsychopharmacology. 2019 Jun;44(7):1233-1238. doi: 10.1038/s41386-019-0317-8. Epub 2019 Jan 17.
Background: PubMed 32064416Drapkin J, Masoudi A, Butt M, Hossain R, Likourezos A, Motov S. Administration of Nebulized Ketamine for Managing Acute Pain in the Emergency Department: A Case Series. Clin Pract Cases Emerg Med. 2020 Jan 2;4(1):16-20. doi: 10.5811/cpcem.2019.10.44582. eCollection 2020 Feb.
Background: PubMed 27018176Gao M, Rejaei D, Liu H. Ketamine use in current clinical practice. Acta Pharmacol Sin. 2016 Jul;37(7):865-72. doi: 10.1038/aps.2016.5. Epub 2016 Mar 28.
Background: PubMed 33726522McIntyre RS, Rosenblat JD, Nemeroff CB, Sanacora G, Murrough JW, Berk M, Brietzke E, Dodd S, Gorwood P, Ho R, Iosifescu DV, Lopez Jaramillo C, Kasper S, Kratiuk K, Lee JG, Lee Y, Lui LMW, Mansur RB, Papakostas GI, Subramaniapillai M, Thase M, Vieta E, Young AH, Zarate CA Jr, Stahl S. Synthesizing the Evidence for Ketamine and Esketamine in Treatment-Resistant Depression: An International Expert Opinion on the Available Evidence and Implementation. Am J Psychiatry. 2021 May 1;178(5):383-399. doi: 10.1176/appi.ajp.2020.20081251. Epub 2021 Mar 17.
Background: PubMed 35509843Yavi M, Lee H, Henter ID, Park LT, Zarate CA Jr. Ketamine treatment for depression: a review. Discov Ment Health. 2022;2(1):9. doi: 10.1007/s44192-022-00012-3. Epub 2022 Apr 15.
Background: PubMed 33609274Kohtala S. Ketamine-50 years in use: from anesthesia to rapid antidepressant effects and neurobiological mechanisms. Pharmacol Rep. 2021 Apr;73(2):323-345. doi: 10.1007/s43440-021-00232-4. Epub 2021 Feb 20.
Background: PubMed 26824031Park M, Niciu MJ, Zarate CA Jr. Novel Glutamatergic Treatments for Severe Mood Disorders. Curr Behav Neurosci Rep. 2015 Dec;2(4):198-208. doi: 10.1007/s40473-015-0050-5. Epub 2015 Oct 9.
Background: PubMed 23982301Murrough JW, Iosifescu DV, Chang LC, Al Jurdi RK, Green CE, Perez AM, Iqbal S, Pillemer S, Foulkes A, Shah A, Charney DS, Mathew SJ. Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial. Am J Psychiatry. 2013 Oct;170(10):1134-42. doi: 10.1176/appi.ajp.2013.13030392.
Background: PubMed 31378256Witkin JM, Martin AE, Golani LK, Xu NZ, Smith JL. Rapid-acting antidepressants. Adv Pharmacol. 2019;86:47-96. doi: 10.1016/bs.apha.2019.03.002. Epub 2019 Apr 24.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jessica Poster, MD contact

718-283-8170

JPoster@maimo.org

Theresa Jacob, PhD, MPH study director

Maimonides Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nebulized ketamine and nebulized midazolam in people with Severe Depression and Moderate Depression, run by Theresa Jacob, PhD, MPH at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jessica Poster, MD (718-283-8170, JPoster@maimo.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: 8-10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06752759, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.