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Cobot TS MV robotic arm for TMS / NeurOptics PLRTM-30000 Pupillometer / Ketamine · Phase 1 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 1 study registration examining ketamine's neuropharmacodynamic effects via neuroimaging (fMRI, EEG, MEG) and biomarkers in 150 participants with major depressive disorder and healthy volunteers. No efficacy or safety results are posted; the trial remains in recruitment status.
Phase 1, Interventional, Randomized, Crossover, Double masking, Treatment purpose. Healthy Volunteer, Major Depressive Disorder, Depression; age from 18 Years; to 65 Years; accepts healthy volunteers. Intervention: Metabolites Substudy; Phase I; Phase II, Arm 1; Phase II, Arm 1b; Phase III. Compared with: Phase II, Arm 2 — Placebo Comparator; Phase II, Arm 2b — Placebo Comparator; Phase IV — No Intervention. n = 150. 1 site: United States.
This is a planned Phase 1 study registration examining ketamine's neuropharmacodynamic effects via neuroimaging (fMRI, EEG, MEG) and biomarkers in 150 participants with major depressive disorder and healthy volunteers. No efficacy or safety results are posted; the trial remains in recruitment status.
Primary outcomes are neuropharmacodynamic imaging measures, not clinical efficacy or safety events.
This registry record describes a planned mechanistic study of ketamine's brain effects, not a clinical efficacy trial. Clinicians should await publication of results before using this to inform ketamine treatment decisions; the imaging biomarker focus means clinical outcomes are secondary.
This is a Phase 1 interventional trial registration with no posted results; it describes a planned study of ketamine neuropharmacodynamics in depression using imaging biomarkers, still in recruitment.
As stated by the source record.
Quoted from the source exactly as published.
This registry record describes a planned mechanistic study of ketamine's brain effects, not a clinical efficacy trial. Clinicians should await publication of results before using this to inform ketamine treatment decisions; the imaging biomarker focus means clinical outcomes are secondary.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT03065335). This is a study registration, not published results. Lead sponsor: National Institute of Mental Health (NIMH). Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: Healthy Volunteer, Major Depressive Disorder, Depression. Interventions: DRUG: Ketamine; OTHER: Placebo; DEVICE: Cobot TS MV robotic arm for TMS; DEVICE: NeurOptics PLRTM-30000 Pupillometer. Primary outcome measures: To demonstrate more robust neuropharmacodynamic effects measured by neuropharmacodynamic imaging (fMRI+EEG and MEG) of ketamine 0.5 mg/kg as compared to placebo administered over 40 minutes. , Multiple; Ketamine Metabolites Substudy: To determine if ketamine metabolites cross the blood brain barrier and enter the brain during ketamine IV administration. , Multiple. Brief summary: Background: Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect. Objective: Main Study: To study the effects of ketamine in treating depression. Ketamine Metabolites Substudy: To study how ketamine effects brain chemistry. To study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down. Eligibility: Main Study: People ages 18-65 with major depressive disorder and healthy volunteers Ketamine Metabolites Substudy: Healthy volunteers ages 18-65 Design: Main Study: Participants will be screened in another study, with: * Medical and psychiatric history * Psychiatric and physical exam * Blood, urine, and heart tests Participants will be inpatients at NIH for 4 phases totaling 14-20 weeks. Phase I (2-7 weeks): * Gradually stop current medications * MRI: Participants lie and perform tasks in a machine that takes pictures of the body. * Mood and thinking tests * Blood and urine tests * Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep. * Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity. * Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks. Phase I tests are repeated in Phases II and III and in the final visit. Phase II (4-5 weeks): * 4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity. Phase III (optional): * 8 infusions of ketamine over 4 weeks Phase IV (optional): * Symptoms monitoring for 4 weeks * Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months. Ketamine Metabolites Substudy: Participants will be screened in another study, with: * Medical and psychiatric history * Psychiatric and physical exam * Blood, urine, and heart tests Participants will be inpatients at NIH for 4 days. Study Procedures: Mood and thinking tests Blood and urine tests 1 infusion of ketamine Spinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry ...
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