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RecruitingNot applicable

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

NCT07563868 · Massachusetts General Hospital

Recruiting
Status
Accepting participants
Not applicable
Phase
20
Target enrolment
2
Study sites
1 US states

What it is testing

Summary

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. Participation in the study will involve adding coaching sessions to your existing ketamine maintenance treatment.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment.

    Measured over From enrollment to the end of treatment at Month 3

  • To assess the acceptability of adjunctive coaching during ketamine/esketamine maintenance treatment.

    Measured over From enrollment to the end of treatment at Month 3

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Age 18 years or older at the time of informed consent/study enrollment. 2. Ability to understand and provide informed consent. 3. Fluent in English (spoken and written). 4. Willingness to have coaching sessions recorded via HIPAA-compliant MGB approved video-based platform. 5. Has a QIDS-SR score ≥ 11, indicating at least moderate depressive symptom severity at screening visit. 6. Lifetime diagnosis of a depressive disorder according to the MINI. 7. 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). 8. 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. 9. 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. 10. Has established care with a mental health provider (e.g., psychiatrist, therapist, or other licensed mental health clinician), and, if outside the MGB-healthcare system, agrees to sign a Release of Information form (ROI) with the study team. Exclusion Criteria: 1. Presence of an unstable medical condition, as determined by the study clinician. 2. Significant neurocognitive impairment that impairs with individual's ability to maintain ADLs and would interfere with study participation, per study clinician judgment. 3. Newly initiated psychotherapy within the past 3 months. 4. Any condition or circumstance that, in the judgment of the Principal Investigator, makes participation unsafe or unsuitable. 5. Any psychiatric condition that is currently primary, clinically predominant to their depression, or insufficiently stable such that it would interfere with study participation, per clinician judgment. 6. Plan to switch from IV ketamine treatment to intranasal esketamine or plan to switch from intranasal esketamine to IV ketamine treatment at any point during study. 7. Suicidality determined by the judgment of the study clinicians at screen, with a plan to act in next 6 months. 8. A ≥25% reduction in QIDS total score from screen to baseline visit.

Where

2 study sites

FacilityCityRegionCountry
Massachusetts General Hospital's Depression and Clinical Research programBostonMassachusettsUnited States
Massachusetts General HospitalBostonMassachusettsUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07563868 on ClinicalTrials.gov →

Last updated in the registry 2026-07-23. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits