Depression - Major Depressive DisorderNCT07422519
Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression
A study testing Virtual-Reality-based mindfulness intervention and Esketamine Treatment as Usual (ESK) in people with Depression - Major Depressive Disorder and Depression Disorder, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Depression Disorder, Depression Chronic
- What is being tested?
- Virtual-Reality-based mindfulness intervention and Esketamine Treatment as Usual (ESK)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 18 Sep 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Dr. J. Antoni Ramos-Quiroga, +3493 274 6087, antoni.ramos@vallhebron.cat
About this study
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
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:
Read more
- Does the combined intervention lead to changes in inflammatory blood parameters compared with pharmacological treatment alone?
- Does the addition of a VR-based mindfulness intervention prolong remission of depressive symptoms six months after treatment completion?
- Is the combined treatment with mindfulness and esketamine well-tolerated, and how does its adverse effect profile compare with esketamine treatment alone?
- 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.
Read the detailed description
Major Depressive Disorder (MDD) is a highly prevalent condition and one of the leading causes of disability worldwide. It is associated with increased mortality, higher risk of suicidal behaviour, and frequent comorbidity with somatic conditions such as obesity, cardiovascular disease, and cognitive impairment. Despite its clinical impact, available psychopharmacological treatments are suboptimal, with a substantial proportion of patients showing an inadequate response to first-line antidepressant therapies. This has led to the concept of treatment-resistant depression (TRD), generally understood as the failure to achieve response or remission after treatment with at least two antidepressants with different mechanisms of action.
At present, there is no standardised treatment algorithm for TRD. Commonly used strategies include combinations of antidepressants, pharmacological augmentation, and physical treatment approaches; however, none of these options is specifically indicated for TRD, and the evidence supporting their effectiveness remains limited. Esketamine, the S-enantiomer of racemic ketamine, is an antidepressant that acts as an N-methyl-D-aspartate (NMDA) receptor antagonist and enhances glutamatergic neurotransmission. This mechanism of action has demonstrated efficacy in patients with TRD, leading to its approval for this indication. Esketamine is administered intranasally using a treatment schedule that includes an induction phase followed by a maintenance phase and is considered part of routine pharmacological care for TRD in the study setting.
For a comprehensive approach to TRD, psychological treatment options should also be considered. When combined with pharmacological treatment, psychotherapy has been shown to provide additional benefit for patients with TRD by facilitating learning, coping, and resilience processes that may act synergistically with the biological mechanisms of antidepressant treatments. Among the psychological approaches studied in depression, mindfulness-based interventions focus on practices that promote acceptance of the present moment and the development of effective self-care and coping skills and have shown promising effects in depressive disorders.
In recent years, the combination of mindfulness-based interventions with virtual reality (VR) has been promoted. VR allows individuals to interact with computer-generated environments within a simulated scenario and offers the possibility of creating immersive and aesthetically engaging settings adapted to therapeutic needs. Similar to traditional mindfulness-based interventions, VR-based approaches provide guided meditative experiences, with audio guidance supporting standardisation and consistency of intervention delivery. An additional advantage of VR-based mindfulness interventions is their potential sustainability, as they do not require additional personnel resources.
Given the limitations of current treatment options for TRD, it is important to explore innovative interventions that may improve therapeutic outcomes. The combination of pharmacological treatment with mindfulness therapy delivered through VR represents a promising approach due to its potential to foster present-moment acceptance and effective coping skills. In addition, TRD has been repeatedly associated with altered immune cellular function and elevated circulating pro-inflammatory markers, making it relevant to examine biological parameters alongside clinical improvement.
In summary, this study aims to explore the potential value of adding a mindfulness-based intervention delivered through virtual reality to standard pharmacological treatment in patients with treatment-resistant depression. By building on existing clinical practice within a specialised programme, this pilot study seeks to generate preliminary evidence to inform future research and the development of integrated treatment approaches for TRD.
- Conditions
- Depression - Major Depressive Disorder, Depression Disorder, Depression Chronic, Treatment-Resistant Major Depressive Disorder
- Being tested
- Virtual-Reality-based mindfulness intervention, Esketamine Treatment as Usual (ESK)
- Keywords
- Treatment-Resistant Depression, Major Depressive Disorder, Mindfulness-Based Intervention, Virtual Reality, Esketamine
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual-Reality-based mindfulness interventionBehavioural
The mindfulness-based intervention will be delivered using a virtual reality (VR) platform (Sunrise Serenity) developed by XRHealth. The intervention consists of a 10-minute guided mindfulness meditation presented in a 360-degree immersive virtual environment depicting a seaside scene at sunrise.
Participants will use a Pico Neo 2 VR headset with handheld controllers. The intervention software will be pre-installed on the device to ensure standardised delivery. Prior to the first intervention session, participants will complete a 5-minute familiarisation period with the VR equipment to ensure comfort and proper use.
The VR-based mindfulness session will be administered immediately before each intranasal esketamine treatment during the induction phase (weeks 1-4; 8 sessions in total).
The software used is patented and certified for medical use, with regulatory approval from the U.S. Food and Drug Administration (FDA) and CE marking.
Esketamine Treatment as Usual (ESK)Drug
The treatment with intranasal esketamine for treatment-resistant depression includes two phases. Induction Phase (Weeks 1-4): Following diagnosis of treatment-resistant depression, participants will receive intranasal esketamine twice weekly for four weeks. At the first treatment session, a total dose of 56 mg (two 28 mg devices) will be administered. In subsequent sessions, the dose may be adjusted according to individual tolerability and clinical judgement. Maintenance Phase (Weeks 5-30): After completion of the induction phase, participants will enter a maintenance phase in which esketamine will be administered once weekly for four weeks, followed by administration once every two weeks until the end of the treatment period. Doses of 56 mg or 84 mg will be administered based on clinical response and tolerability, with dose adjustments made according to clinical evolution.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: Esketamine Treatment as Usual (ESK) | Other | Participants allocated to the control arm will receive conventional pharmacological treatment with intranasal esketamine for treatment-resistant depression. Receives: Drug: Esketamine Treatment as Usual (ESK) |
| Experimental Arm: Esketamine Plus Mindfulness (ESK-MIND) | Experimental | Participants allocated to the experimental arm will receive intranasal esketamine in combination with a mindfulness-based intervention delivered via virtual reality.
Induction Phase (Weeks 1-4):
Participants will receive the same intranasal esketamine induction regimen as the control arm. In addition, participants will receive a 10-minute session of virtual reality-based mindfulness therapy immediately prior to each esketamine administration during the induction phase. The mindfulness intervention will be standardised and delivered using immersive virtual environments with guided audio content.
Maintenance Phase (Weeks 5-30):
Following the induction phase, participants will continue with the same esketamine maintenance regimen as the control arm: once-weekly administration for four weeks, followed by once every two weeks until treatment completion. Doses of 56 mg or 84 mg will be administered according to clinical response and tolerability, with adjustments based on clinical course. Receives: Behavioral: Virtual-Reality-based mindfulness intervention; Drug: Esketamine Treatment as Usual (ESK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity in depressive symptoms as assessed by Montgomery-Åsberg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated, 10-item scale used to evaluate the severity of depressive symptoms. Each item is scored from 0 to 6, yielding a total score ranging from 0 to 60, with higher scores indicating greater depression severity.
Measured: Baseline (Week 0), Week 4 (end of the induction phase), Week 30 (end of the maintenance phase), and Week 54 (follow-up)
Secondary outcomes (7)
Clinical Global Impressions - Improvement (CGI-I) and Severity (CGI-S)
The CGI-S is a single-item, clinician-rated measure of the clinician's assessment of the patient's current illness severity relative to the clinician's total experience with patients with the same condition. The CGI-S is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
The CGI-I is a single-item, clinician-rated measure evaluating change in the patient's condition relative to baseline. The CGI-I is rated on a 7-point scale ranging from 1 = very much improved to 7 = very much worse. Lower scores indicate greater improvement.
Measured: Baseline (Week 0), Week 4 (end of induction), Week 30 (end of maintenance), and Week 54 (follow-up)
Self-reported depressive symptoms as assessed by the Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire designed to measure the severity of depressive symptoms, with total scores ranging from 0 to 63. Scores are calculated by summing the 0-3 ratings for each item, where higher scores indicate greater severity.
Measured: Baseline (Week 0), Week 4 (end of induction), Week 30 (end of maintenance), and Week 54 (follow-up)
Global functioning as assessed by Global Assessment of Functioning (GAF)
The Global Assessment of Functioning (GAF) scale is a 0-100 numerical rating assessing a person's overall psychological, social, and occupational functioning. It measures how symptoms affect daily life, with higher scores indicating better functioning and lower scores indicating severe impairment.
Measured: Baseline (Week 0), Week 4 (end of induction), Week 30 (end of maintenance), and Week 54 (follow-up)
Functional impairment as assessed by Sheehan Disability Scale (SDS)
The Sheehan Disability Scale (SDS) is a self-rated, 3-item questionnaire assessing functional impairment across three domains: work/school, social life, and family life/home responsibilities. Each domain is rated on a 10-point visual analogue scale ranging from 0 = no impairment to 10 = extreme impairment, yielding a total score ranging from 0 to 30, with higher scores indicating greater functional impairment.
Measured: Baseline (Week 0), Week 4 (end of induction), Week 30 (end of maintenance), and Week 54 (follow-up)
Dissociative symptoms as assessed by the Clinician-Administered Dissociative States Scale (CADSS)
The Clinician-Administered Dissociative States Scale (CADSS) is a clinician-administered scale designed to measure present-state dissociative symptoms. The scale includes 23 items, each rated from 0 = not at all to 4 = extremely. Item scores are summed to yield a total score ranging from 0 to 92, with higher scores indicating greater dissociative symptom severity.
Measured: During the induction phase, approximately 1.5 hours after each dose, through Week 4 (end of induction phase).
Mindfulness trait levels as assessed by Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
The FFMQ-SF is a self-report instrument that assesses five domains of mindfulness: Observing, Describing, Acting with Awareness, Nonjudging of Inner Experience, and Nonreactivity to Inner Experience. The short form consists of 24 items, each rated on a 5-point Likert scale ranging from 1 = never or very rarely true to 5 = very often or always true. Item scores are summed to yield a total score, with higher scores indicating greater levels of trait mindfulness.
Measured: Baseline (Week 0), Week 4 (end of the induction phase)
The incidence of adverse events
Treatment tolerability and safety as assessed by the incidence, nature, and severity of adverse events, including treatment-emergent adverse events (TEAEs).
Measured: Throughout the study period (up to Week 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start18 Sep 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422519
- Sponsor's protocol ID
- PR(AG)494/2024
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07422519
- Acronym / sponsor ID
- PR(AG)494/2024
- Conditions
- Depression - Major Depressive Disorder, Depression Disorder, Depression Chronic, Treatment-Resistant Major Depressive Disorder
- Keywords
- Treatment-Resistant Depression, Major Depressive Disorder, Mindfulness-Based Intervention, Virtual Reality, Esketamine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the combined intervention lead to changes in inflammatory blood parameters compared with pharmacological treatment alone?
- Does the addition of a VR-based mindfulness intervention prolong remission of depressive symptoms six months after treatment completion?
- Is the combined treatment with mindfulness and esketamine well-tolerated, and how does its adverse effect profile compare with esketamine treatment alone?
- 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.
Detailed description
Major Depressive Disorder (MDD) is a highly prevalent condition and one of the leading causes of disability worldwide. It is associated with increased mortality, higher risk of suicidal behaviour, and frequent comorbidity with somatic conditions such as obesity, cardiovascular disease, and cognitive impairment. Despite its clinical impact, available psychopharmacological treatments are suboptimal, with a substantial proportion of patients showing an inadequate response to first-line antidepressant therapies. This has led to the concept of treatment-resistant depression (TRD), generally understood as the failure to achieve response or remission after treatment with at least two antidepressants with different mechanisms of action.
At present, there is no standardised treatment algorithm for TRD. Commonly used strategies include combinations of antidepressants, pharmacological augmentation, and physical treatment approaches; however, none of these options is specifically indicated for TRD, and the evidence supporting their effectiveness remains limited. Esketamine, the S-enantiomer of racemic ketamine, is an antidepressant that acts as an N-methyl-D-aspartate (NMDA) receptor antagonist and enhances glutamatergic neurotransmission. This mechanism of action has demonstrated efficacy in patients with TRD, leading to its approval for this indication. Esketamine is administered intranasally using a treatment schedule that includes an induction phase followed by a maintenance phase and is considered part of routine pharmacological care for TRD in the study setting.
For a comprehensive approach to TRD, psychological treatment options should also be considered. When combined with pharmacological treatment, psychotherapy has been shown to provide additional benefit for patients with TRD by facilitating learning, coping, and resilience processes that may act synergistically with the biological mechanisms of antidepressant treatments. Among the psychological approaches studied in depression, mindfulness-based interventions focus on practices that promote acceptance of the present moment and the development of effective self-care and coping skills and have shown promising effects in depressive disorders.
In recent years, the combination of mindfulness-based interventions with virtual reality (VR) has been promoted. VR allows individuals to interact with computer-generated environments within a simulated scenario and offers the possibility of creating immersive and aesthetically engaging settings adapted to therapeutic needs. Similar to traditional mindfulness-based interventions, VR-based approaches provide guided meditative experiences, with audio guidance supporting standardisation and consistency of intervention delivery. An additional advantage of VR-based mindfulness interventions is their potential sustainability, as they do not require additional personnel resources.
Given the limitations of current treatment options for TRD, it is important to explore innovative interventions that may improve therapeutic outcomes. The combination of pharmacological treatment with mindfulness therapy delivered through VR represents a promising approach due to its potential to foster present-moment acceptance and effective coping skills. In addition, TRD has been repeatedly associated with altered immune cellular function and elevated circulating pro-inflammatory markers, making it relevant to examine biological parameters alongside clinical improvement.
In summary, this study aims to explore the potential value of adding a mindfulness-based intervention delivered through virtual reality to standard pharmacological treatment in patients with treatment-resistant depression. By building on existing clinical practice within a specialised programme, this pilot study seeks to generate preliminary evidence to inform future research and the development of integrated treatment approaches for TRD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm: Esketamine Treatment as Usual (ESK) | Other | Drug: Esketamine Treatment as Usual (ESK)Participants allocated to the control arm will receive conventional pharmacological treatment with intranasal esketamine for treatment-resistant depression. |
| Experimental Arm: Esketamine Plus Mindfulness (ESK-MIND) | Experimental | Behavioral: Virtual-Reality-based mindfulness intervention, Drug: Esketamine Treatment as Usual (ESK)Participants allocated to the experimental arm will receive intranasal esketamine in combination with a mindfulness-based intervention delivered via virtual reality. Induction Phase (Weeks 1-4): Participants will receive the same intranasal esketamine induction regimen as the control arm. In addition, participants will receive a 10-minute session of virtual reality-based mindfulness therapy immediately prior to each esketamine administration during the induction phase. The mindfulness intervention will be standardised and delivered using immersive virtual environments with guided audio content. Maintenance Phase (Weeks 5-30): Following the induction phase, participants will continue with the same esketamine maintenance regimen as the control arm: once-weekly administration for four weeks, followed by once every two weeks until treatment completion. Doses of 56 mg or 84 mg will be administered according to clinical response and tolerability, with adjustments based on clinical course. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual-Reality-based mindfulness interventionThe mindfulness-based intervention will be delivered using a virtual reality (VR) platform (Sunrise Serenity) developed by XRHealth. The intervention consists of a 10-minute guided mindfulness meditation presented in a 360-degree immersive virtual environment depicting a seaside scene at sunrise. Participants will use a Pico Neo 2 VR headset with handheld controllers. The intervention software will be pre-installed on the device to ensure standardised delivery. Prior to the first intervention session, participants will complete a 5-minute familiarisation period with the VR equipment to ensure comfort and proper use. The VR-based mindfulness session will be administered immediately before each intranasal esketamine treatment during the induction phase (weeks 1-4; 8 sessions in total). The software used is patented and certified for medical use, with regulatory approval from the U.S. Food and Drug Administration (FDA) and CE marking. | Behavioural | Experimental Arm: Esketamine Plus Mindfulness (ESK-MIND) |
| Esketamine Treatment as Usual (ESK)The treatment with intranasal esketamine for treatment-resistant depression includes two phases. Induction Phase (Weeks 1-4): Following diagnosis of treatment-resistant depression, participants will receive intranasal esketamine twice weekly for four weeks. At the first treatment session, a total dose of 56 mg (two 28 mg devices) will be administered. In subsequent sessions, the dose may be adjusted according to individual tolerability and clinical judgement. Maintenance Phase (Weeks 5-30): After completion of the induction phase, participants will enter a maintenance phase in which esketamine will be administered once weekly for four weeks, followed by administration once every two weeks until the end of the treatment period. Doses of 56 mg or 84 mg will be administered based on clinical response and tolerability, with dose adjustments made according to clinical evolution. | Drug | Control Arm: Esketamine Treatment as Usual (ESK), Experimental Arm: Esketamine Plus Mindfulness (ESK-MIND) |
Primary outcome
Severity in depressive symptoms as assessed by Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Baseline (Week 0), Week 4 (end of the induction phase), Week 30 (end of the maintenance phase), and Week 54 (follow-up)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated, 10-item scale used to evaluate the severity of depressive symptoms. Each item is scored from 0 to 6, yielding a total score ranging from 0 to 60, with higher scores indicating greater depression severity.
7 secondary outcomes
Clinical Global Impressions - Improvement (CGI-I) and Severity (CGI-S)
Time frame: Baseline (Week 0), Week 4 (end of induction), Week 30 (end of maintenance), and Week 54 (follow-up)
Self-reported depressive symptoms as assessed by the Beck Depression Inventory (BDI)
Time frame: Baseline (Week 0), Week 4 (end of induction), Week 30 (end of maintenance), and Week 54 (follow-up)
Global functioning as assessed by Global Assessment of Functioning (GAF)
Time frame: Baseline (Week 0), Week 4 (end of induction), Week 30 (end of maintenance), and Week 54 (follow-up)
Functional impairment as assessed by Sheehan Disability Scale (SDS)
Time frame: Baseline (Week 0), Week 4 (end of induction), Week 30 (end of maintenance), and Week 54 (follow-up)
Dissociative symptoms as assessed by the Clinician-Administered Dissociative States Scale (CADSS)
Time frame: During the induction phase, approximately 1.5 hours after each dose, through Week 4 (end of induction phase).
Mindfulness trait levels as assessed by Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
Time frame: Baseline (Week 0), Week 4 (end of the induction phase)
The incidence of adverse events
Time frame: Throughout the study period (up to Week 30)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Depression - Major Depressive Disorder
Recruiting
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
Major Depressive Disorder
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
Major Depressive Disorder (MDD), Depression in Adults
RecruitingObservational study
The Immunobiological Mechanisms of Depression in Perimenopause
Perimenopause, Major Depressive Episode (MDE)
Not yet recruiting
Effectiveness of Internet-based Unified Protocol (iUP) for Emotional Problems: A Randomized Controlled Trial
Depression - Major Depressive Disorder, Generalised Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual-Reality-based mindfulness intervention and Esketamine Treatment as Usual (ESK) in people with Depression - Major Depressive Disorder and Depression Disorder, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. J. Antoni Ramos-Quiroga (+3493 274 6087, antoni.ramos@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity in depressive symptoms as assessed by Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: Baseline (Week 0), Week 4 (end of the induction phase), Week 30 (end of the maintenance phase), and Week 54 (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.