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New treatment option for Treatment Resistant Depression (TRD)
Official title Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT07563868
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older at the time of informed consent/study enrollment.
- Ability to understand and provide informed consent.
- 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.
You likely can't join if
- Presence of an unstable medical condition, as determined by the study clinician.
- Significant neurocognitive impairment that impairs with individual's ability to maintain ADLs and would interfere with study participation, per study...
- Newly initiated psychotherapy within the past 3 months.
- Any condition or circumstance that, in the judgment of the Principal Investigator, makes participation unsafe or unsuitable.
- Any psychiatric condition that is currently primary, clinically predominant to their depression, or insufficiently stable such that it would...
- Plan to switch from IV ketamine treatment to intranasal esketamine or plan to switch from intranasal esketamine to IV ketamine treatment at any point...
See the full eligibility criteria
- Age 18 years or older at the time of informed consent/study enrollment.
- Ability to understand and provide informed consent.
- 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...
- 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...
- Presence of an unstable medical condition, as determined by the study clinician.
- Significant neurocognitive impairment that impairs with individual's ability to maintain ADLs and would interfere with study participation, per study clinician judgment.
- Newly initiated psychotherapy within the past 3 months.
- Any condition or circumstance that, in the judgment of the Principal Investigator, makes participation unsafe or unsuitable.
- 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.
- 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.
- Suicidality determined by the judgment of the study clinicians at screen, with a plan to act in next 6 months.
- A ≥25% reduction in QIDS total score from screen to baseline visit.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.