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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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Psychedelic Integration Coaching for Treatment Resistant Depression (TRD)

This study is being conducted at Massachusetts General Hospital (MGH) to explore whether adding psychedelic coaching can enhance the effects of ketamine or esketamine maintenance treatment in individuals with treatment-resistant depression (TRD). The investigators are currently enrolling participants who are receiving ongoing maintenance intravenous (IV) ketamine or intranasal esketamine (Spravato) treatment at the MGH Ketamine Clinic.

Official registry: https://clinicaltrials.gov/study/NCT07563868 · Massachusetts General Hospital · enrollment listed as 20

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

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 Psychedelic Integration Coaching. The registry lists allocation as na. This study is being conducted at Massachusetts General Hospital (MGH) to explore whether adding psychedelic coaching can enhance the effects of ketamine or esketamine maintenance treatment in individuals with treatment-resistant depression (TRD).

They plan to enroll about 20 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression

Interventions: Psychedelic Integration Coaching

Primary outcome (registry wording): To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment.

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Fluent in English (spoken and written)
  • Willingness to have coaching sessions recorded via HIPAA-compliant MGB approved video-based platform
  • Has a QIDS-SR score ≥ 11, indicating at least moderate depressive symptom severity at screening visit
  • Lifetime diagnosis of a depressive disorder according to the MINI
  • In the maintenance phase of ketamine or esketamine treatment, defined as the period following the initial acute treatment series (typically 2 treatments per week for 3 weeks)
  • Patients must have completed at least 3 maintenance treatments prior to screening visit with a QIDS-SR score ≥ 11 noted from EPIC medical records from the 3 most recent maintenance treatments
  • Currently receiving maintenance IV ketamine or intranasal esketamine at the MGH Ketamine Clinic, with at least one treatment administered within the past 8 weeks, and planning to continue to be an active patient at the MGH Ketamine Clinic for the duration of the study

Public study contact (from the registry)

Maren Nyer, PhD

6176434897

mnyer@mgh.harvard.edu

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

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT07563868 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 NCT07563868?

Not a traditional drug phase. 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 NCT07563868?

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