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 2interventionalRules rewrite

Phase 2: testing Ketamine for Major Depressive Disorder

The proposed study is a single-site, randomly assigned, controlled clinical trial (RCT) comparing ketamine-assisted psychotherapy (KAP) to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy (KET). Eligible study you would be adults with major depressive disorder (major depression).

Official registry: https://clinicaltrials.gov/study/NCT06559826 · Icahn School of Medicine at Mount Sinai · enrollment listed as 70

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more 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, or Psychotherapy. The registry lists allocation as randomized. The proposed study is a single-site, randomly assigned, controlled clinical trial (RCT) comparing ketamine-assisted psychotherapy (KAP) to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy (KET).

They plan to enroll about 70 people at New York. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

A Randomized-Controlled Trial of Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression

Interventions: Ketamine, Psychotherapy

Primary outcome (registry wording): Montgomery-Asberg Depression Rating Scale (MADRS)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 90 Years
  • Participant in good physical health
  • Participants may be on medications for depression as long as they remain on a stable dose
  • A score of at least 20 on the 10 item Montgomery-Asberg Depression Scale at screening, corresponding to at least moderate current depression severity
  • Meets criteria for major depressive disorder (major depression) in current major depressive episode (MDE) according to DSM-5
  • Women of child-bearing potential must have a negative pregnancy test at screening and prior to ketamine infusion

Public study contact (from the registry)

Rachel Fremont, MD, PhD

212-241-6539

rachel.fremont@mssm.edu

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 NCT06559826 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 NCT06559826?

Phase 2. 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 NCT06559826?

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