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.
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
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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