Virtual reality mindfulness added to usual esketamine care for hard-to-treat depression
Official title: A Pilot Randomised Controlled Study Evaluating the Efficacy and Tolerability of Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression
Run by Hospital Universitari Vall d'Hebron Research Institute · NCT07422519 · Data updated 2026-11-12
This will test whether adding a virtual-reality mindfulness program to usual esketamine treatment helps adults with treatment-resistant depression feel less depressed.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 74 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | September 18, 2025 |
| Main results expected | December 15, 2026 |
| Study ends | December 15, 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07422519 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–74 with treatment-resistant major depressive disorder who have failed at least two antidepressants and one augmentation or combination strategy are the intended participants.
✕Probably not a fit
Patients with contraindications to esketamine, those currently in another interventional antidepressant trial, or those with medical or psychiatric conditions that would interfere with participation are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares a combined virtual reality (VR)-based mindfulness intervention plus standard esketamine treatment to esketamine treatment alone in adults with treatment-resistant major depressive disorder. Participants receive the pharmacological induction and maintenance schedule of intranasal esketamine while one group also undergoes guided VR mindfulness sessions as an adjunct. Outcomes include changes in depressive symptom severity, inflammatory blood markers, mindfulness trait measures (FFMQ-SF), tolerability and adverse events, and duration of remission up to six months after treatment. The trial recruits eligible adults at Hospital Universitari Vall d'Hebron and follows them through treatment and follow-up assessments.
Why it matters
Potential benefit: If successful, adding VR mindfulness to esketamine could reduce depressive symptoms and help sustain remission longer than medication alone.
How similar studies have gone: Esketamine has demonstrated efficacy in TRD and mindfulness or VR interventions have shown promising results in smaller studies, but the specific combination of VR mindfulness plus esketamine is relatively untested in larger controlled trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 74 years, inclusive * Diagnosis of treatment-resistant Major Depressive Disorder (MDD), single or recurrent episode, in accordance with DSM-5 diagnostic criteria. * Inadequate response to two or more oral antidepressants during the current depressive episode * Inadequate response to at least one pharmacological combination or augmentation strategy * Ability and willingness to provide written informed consent for participation and data collection Exclusion Criteria: * Presence of any contraindication to esketamine administration according to the approved product label * Current participation in another interventional clinical study involving antidepressant medication * Any medical, psychiatric, or other condition that, in the opinion of the investigator, could: (a) compromise participant safety or well-being, or (b) interfere with, limit, or confound study assessments or outcomes
Where it's running
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Hospital Universitari Vall d'Hebron
Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Dr. J. Antoni Ramos-Quiroga
- Email: antoni.ramos@vallhebron.cat
- Phone: +3493 274 6087
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.