NCT06752759 Nebulized Ketamine for the Treatment of Major Depressive Disorder
| NCT ID | NCT06752759 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Theresa Jacob, PhD, MPH |
| Condition | Severe Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-10-16 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2024-10-16 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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
Contact & Investigator
Theresa Jacob, PhD, MPH
STUDY DIRECTOR
Maimonides Medical Center
Frequently Asked Questions
Who can join the NCT06752759 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 88 Years, studying Severe Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06752759 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT06752759 currently recruiting?
Yes, NCT06752759 is actively recruiting participants. Contact the research team at JPoster@maimo.org for enrollment information.
Where is the NCT06752759 trial being conducted?
This trial is being conducted at Brooklyn, United States.
Who is sponsoring the NCT06752759 clinical trial?
NCT06752759 is sponsored by Theresa Jacob, PhD, MPH. The principal investigator is Theresa Jacob, PhD, MPH at Maimonides Medical Center. The trial plans to enroll 40 participants.
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