Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Ketamine for Healthy Volunteer

Background: Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments.

Official registry: https://clinicaltrials.gov/study/NCT03065335 · National Institute of Mental Health (NIMH) · enrollment listed as 150

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Ketamine, Placebo, or Cobot TS MV robotic arm for TMS. The registry lists allocation as randomized. Background: Most medications that treat depression take weeks or months to work.

They plan to enroll about 150 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.

Official title (unrewritten)

Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder

Interventions: Ketamine, Placebo, Cobot TS MV robotic arm for TMS, NeurOptics PLRTM-30000 Pupillometer

Primary outcome (registry wording): 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.

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • who can join: All Subjects (Main Study)
  • 18 to 65 years of age
  • Agree to be hospitalized
  • Additional who can join: Patients with major depression (Main Study)
  • At the initial study enrollment, subjects must have fulfilled DSM-IV or DSM-5 criteria for Major Depression, single episode or recurrent. Subjects must be experiencing a current major depressive episode of at least 2 weeks duration
  • At the initial screening and beginning of Phases II and III, subjects must have a baseline score on the MADRS \>= 20 and YMRS of \< 12
  • Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial

Public study contact (from the registry)

Adilah M Kirton

(301) 549-0315

adilah.meredith-kirton@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT03065335 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT03065335?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT03065335?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary