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.
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Arm 1, 2, 3 drug Interventions for Depression

Background: Most drugs that treat mood disorders take a long time to work. Certain receptors in the brain might help ketamine work.

Official registry: https://clinicaltrials.gov/study/NCT03973268 · National Institute of Mental Health (NIMH) · enrollment listed as 70

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 Arm 1, 2, 3 device interventions, Arm 2 Interventions, or Arm 1, 2, 3 drug Interventions. The registry lists allocation as randomized. Background: Most drugs that treat mood disorders take a long time to work.

They plan to enroll about 70 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)

The Mechanism of Action Underlying Ketamine's Antidepressant Effects: An Investigation of the AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression

Interventions: Arm 1, 2, 3 device interventions, Arm 2 Interventions, Arm 1, 2, 3 drug Interventions, Arm 1 and 2 Interventions

Primary outcome (registry wording): Acute Antidepressant Efficacy: Change from baseline Montgomery Asberg Depression Rating Scale (MADRS) score post ketamine infusion

Who it is for (from inclusion criteria)

  • Ages 18 Years to 70 Years
  • 18 to 70 years of age
  • All subjects must have undergone a screening assessment under protocol 01-M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers"
  • Subjects must fulfill DSM-IV or -5criteria for Major Depression (Major Depressive Disorder) without psychotic features, based on clinical assessment and informed by a structured diagnostic interview (SCID-P)
  • Subjects must have an initial score on the MADRS \>= 22 and a YMRS score of \<12 within one week of study entry and upon entry into Phase II
  • Current major depressive episode lasting at least four weeks
  • Agree to be hospitalized
  • Open-Label Ketamine Treatment

Public study contact (from the registry)

Yamila I Carmona

(301) 256-8971

yamila.carmona@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 NCT03973268 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 NCT03973268?

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 NCT03973268?

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