NCT07563868 Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression
| NCT ID | NCT07563868 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Treatment Resistant Depression (TRD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-04 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Maren Nyer, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital and Harvard Medical School
Frequently Asked Questions
Who can join the NCT07563868 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Treatment Resistant Depression (TRD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07563868 currently recruiting?
Yes, NCT07563868 is actively recruiting participants. Contact the research team at mnyer@mgh.harvard.edu for enrollment information.
Where is the NCT07563868 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT07563868 clinical trial?
NCT07563868 is sponsored by Massachusetts General Hospital. The principal investigator is Maren Nyer, PhD at Massachusetts General Hospital and Harvard Medical School. The trial plans to enroll 20 participants.
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