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New treatment option for Severe Depression
Official title Nebulized Ketamine for the Treatment of Major Depressive Disorder
ClinicalTrials.gov ID: NCT06752759
What this study is testing
What is nebulized ketamine?
nebulized ketamine is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for severe depression.
Also referred to as Ketalar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 88
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 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 \ 160 mm Hg, pulse rate \ 150 beats/min, and respiration rate \ 30 breaths/min)
- Consumption of opioids within 24 hours of drug administration
- Acutely intoxicated patients will also be excluded
The study team makes the final eligibility decision.
Where it's taking place
- Brooklyn, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 88 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brooklyn, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.