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RecruitingNot applicable

Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression

NCT07422519 · Hospital Universitari Vall d'Hebron Research Institute

Recruiting
Status
Accepting participants
Not applicable
Phase
30
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The primary aim of this study is to evaluate the efficacy and tolerability of a combined Virtual Reality (VR)-based mindfulness intervention and pharmacological treatment compared with pharmacological treatment alone in reducing depressive symptoms in patients with Treatment-Resistant Depression (TRD). Secondary questions this study aims to address include: 1. Does the combined intervention lead to changes in inflammatory blood parameters compared with pharmacological treatment alone? 2. Does the addition of a VR-based mindfulness intervention prolong remission of depressive symptoms six months after treatment completion? 3. Is the combined treatment with mindfulness and esketamine well-tolerated, and how does its adverse effect profile compare with esketamine treatment alone? 4. Is there an association between changes in mindfulness trait levels, assessed using the FFMQ-SF, and reductions in depressive symptom severity? Participants will be recruited from a Treatment-Resistant Depression Programme and randomly assigned to receive either VR-based mindfulness intervention in addition to treatment as usual or treatment as usual alone. The mindfulness intervention will last one month and include a total of 8 sessions. All participants will undergo comprehensive assessments at baseline and at predefined follow-up time points to evaluate clinical outcomes, inflammatory markers, tolerability, and remission duration.

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

  • Severity in depressive symptoms as assessed by Montgomery-Åsberg Depression Rating Scale (MADRS)

    Measured over Baseline (Week 0), Week 4 (end of the induction phase), Week 30 (end of the maintenance phase), and Week 54 (follow-up)

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 to 74 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
Hospital Universitari Vall d'HebronBarcelonaSpain

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.

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NCT07422519 on ClinicalTrials.gov →

Last updated in the registry 2026-02-27. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits