Coaching plus ketamine: a new hope for stubborn depression?
NCT ID NCT07563868
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times
Summary
This study at Massachusetts General Hospital tests whether adding coaching sessions to standard ketamine or esketamine treatment can help people with treatment-resistant depression. About 20 adults already on maintenance ketamine will receive 12 coaching sessions over 3 months. The goal is to see if coaching is practical, well-liked, and might reduce how often ketamine treatments are needed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Massachusetts General Hospital's Depression and Clinical Research program
RECRUITINGBoston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can magnetic brain stimulation keep depression at bay longer than a drug?
- One-Day brain zaps: a new hope for stubborn depression?
- Can the immune system hold the key to treating resistant mental illness?
- Could group talk boost the benefits of psychedelic therapy for depression?