Major Depression ModerateVR-TMDNCT07146269
Virtual Reality-Augmented At-Home tDCS for Major Depression
A study testing tDCS and VR-based relaxation therapy in people with Major Depression Moderate and Major Depression Severe, run by Technical University of Munich at 1 site in Germany.
Trial summary
The goal of this clinical trial is to investigate the efficacy of combining Virtual Reality (VR)-based relaxation and Transcranial Direct Current Stimulation (tDCS) for treating Major Depression. The main questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression Moderate, Major Depression Severe
- What is being tested?
- tDCS and VR-based relaxation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2025to Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least a moderate depressive episode (MADRS baseline score ≥ 20).
- Patients aged between 18 and 65 years.
- Sufficient cognitive abilities to understand study requirements and instructions (MMSE ≥ 27).
- Stable antidepressant/psychiatric medication for at least two weeks prior to study entry.
Who cannot join
- Currently clinically relevant Axis II disorders.
- Other relevant Axis I disorders (except anxiety disorders).
- Substance use disorders within the last 3 months prior to study entry (excluding nicotine and caffeine dependence).
- Skin lesions at the site of tDCS electrode placement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy
Munich
About this study
Official title: Effectiveness of Virtual Reality-Based Relaxation as an Adjunctive Therapy to Optimize At-Home Transcranial Direct Current Stimulation (tDCS) for Depression: A Randomized Controlled Trial
The goal of this clinical trial is to investigate the efficacy of combining Virtual Reality (VR)-based relaxation and Transcranial Direct Current Stimulation (tDCS) for treating Major Depression.
The main questions this study aims to answer are:
Read more
- Does the combination of VR Relaxation and tDCS at-home result in significantly greater symptom improvement in depression than tDCS alone?
- Are there differences in treatment effectiveness depending on demographic characteristics (e.g., age, gender)?
- Feasibility: What is the level of acceptance and adherence to the combined VR and tDCS therapy compared to tDCS alone?
In a randomized controlled trial, patients will be assigned to either a tDCS + VR group or a tDCS-only group.
The study protocol is the following:
- On the first day, patients complete baseline questionnaires and are then randomly assigned to either the tDCS-only group or the tDCS + VR group.
- Both groups perform home-based treatment five times per week for four weeks, with each session lasting 30 minutes.
- After two weeks, patients return for a follow-up visit to complete questionnaires and assess adherence, side effects, and clinical progress.
- At the end of the four-week treatment period, a final assessment is conducted, including questionnaires and patient feedback.
- After 12-16 weeks (i.e. 2 to 3 months after the last tDCS session) Follow Up Assessment (BDI, MADRS, HDRS, GCI, GAF)
Read the detailed description
Participant Recruitment:
Patients with unipolar or bipolar depression will be recruited from inpatient wards at Klinikum rechts der Isar and outpatient services. After screening for eligibility and obtaining informed consent, participants will be randomized into two groups (1:1), stratified by depression severity (MADRS > or < 30):
Active Group: 4-week home-based combination therapy of tDCS and VR-based relaxation
Control Group: 4-week home-based tDCS without VR relaxation
Treatment Protocol:
at-home tDCS: 2 mA for 30 minutes, electrodes at F3/F4 (bifrontal, over DLPFC), daily Monday to Friday, total 20 sessions. Optional MRI before/after treatment.
VR Relaxation: Nature exposure via VR headset, 30 minutes daily parallel to tDCS, Monday to Friday, 20 sessions.
Assessment Schedule:
Baseline Visit (Visit 1): Informed Consent, demographics, medical history, vital signs, and baseline scales (BDI, MADRS, HDRS, GCI, GAF, CTQ, EHI, FTND). First session in-clinic with training for home use. Up to 5 additional sessions may be conducted in-clinic.
Mid-Treatment (Visit 2): After 2 weeks: vital signs, questionnaires (BDI, MADRS, HDRS, GCI, GAF), therapy adherence (according to number of conducted sessions), side effects, treatment adjustments if needed.
Final Assessment (Visit 3): After 4 weeks: final vitals, questionnaires (BDI, MADRS, HDRS, GCI, GAF), patient satisfaction survey, therapy experience interview.
Follow Up Assessment (Visit 4): After 12-16 weeks: questionnaires (BDI, MADRS, HDRS, GCI, GAF)
Technical data on tDCS use (automatic logging) including time, adherence, etc., will also be recorded.
- Conditions
- Major Depression Moderate, Major Depression Severe
- Being tested
- tDCS, VR-based relaxation therapy
- Keywords
- Non-invasive Brain Stimulation (NIBS), Major Depression, Virtual Reality (VR), Transcranial Direct Current Stimulation (tDCS), tDCS at-home
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Transcranial Direct Current Stimulation delivered at an intensity of 2 mA over electrodes at F3/F4 (bifrontal, over DLPFC), for 30 minutes a day, Monday to Friday, for a total 20 sessions.
VR-based relaxation therapyDevice
Nature exposure via a Virtual Reality (VR) headset, for 30 minutes daily concurrently to tDCS, Monday to Friday, for a total of 20 sessions.
| Study group | Role | What they receive |
|---|---|---|
| tDCS only | Active comparator | Transcranial Direct Current Stimulation (tDCS) at home, 20 sessions, 2mA (5 days/week, for 4 weeks) Receives: Device: tDCS |
| tDCS plus VR | Experimental | Transcranial Direct Current Stimulation (tDCS) at home plus Virtual Reality (VR)-based relaxation 20 sessions, 2mA (5 days/week, for 4 weeks) Receives: Device: tDCS; Device: VR-based relaxation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms assessed by MADRS
Major Depression psychiatric symptoms assessed with the Montgomery Asberg Depression Rating Scale (MADRS). MADRS values are interpreted as follows: 0-6 = No depression, 07-19 = mild, 20-34 = moderate, 35-60 = severe.
Primary outcome is the Difference in MADRS Score from baseline to post-treatment visit (day 29)
Measured: Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).
Secondary outcomes (10)
Clinical Global Impression assessed by CGI-S
Clinical Global Impression - Severity scale (CGI-S). Outcome values are interpreted as follows:
- - Normal, not at all ill
- - Borderline mentally ill
- - Mildly ill
- - Moderately ill
- - Markedly ill
- - Severely ill
- - Among the most extremely ill patients
Measured: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), day 29 (after the full 4 weeks of treatment) and followup in 2-3 Months (after 12-16 weeks of treatment).
Psychosocial functioning assessed by GAF score
Global psychosocial functioning will be assessed using the Global Assessment of Functioning (GAF) scale. Outcome values are interpreted as follows:
91-100 Excellent No symptoms; superior functioning 81-90 Good Minimal symptoms, generally doing well 71-80 Mild Some mild symptoms or difficulties 61-70 Moderate Mild symptoms but generally functioning 51-60 Moderate to serious Moderate symptoms or difficulty in functioning 41-50 Serious Serious symptoms or impairments 31-40 Major impairment Impairment in several areas (e.g., work, school) 21-30 Severe Behavior influenced by delusions, serious communication issues 11-20 Very severe Danger to self/others, gross communication issues 1-10 Extreme Persistent danger of severely hurting self/others 0 Not assessable Insufficient information
Measured: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), day 29 (after the full 4 weeks of treatment) and followup in 2-3 Months (after 12-16 weeks of treatment).
Depressive symptoms assessed by BDI-II
Major Depression psychiatric symptoms assessed with the Beck Depression Inventory (BDI-II). Outcome values are interpreted as follows: 0-13 = Minimal depression, 14-19 = Mild depression, 20-28 = Moderate depression, 29-63 = Severe depression
Measured: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), day 29 (after the full 4 weeks of treatment) and followup in 2-3 Months (after 12-16 weeks of treatment).
Depressive symptoms assessed by HDRS
Major Depression psychiatric symptoms assessed with the Hamilton Depression Rating Scale (HADRS). Outcome values are interpreted as follows: 0-7 = No Depression, 08-16 = mild, 17-23 = moderate, ≥ 24 = severe
Measured: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), day 29 (after the full 4 weeks of treatment) and followup in 2-3 Months (after 12-16 weeks of treatment).
Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between dorsolateral prefrontal cortex (DLPFC) and anterior cingulate cortex (ACC) in a subset of participants
Resting-state fMRI-based Pearson correlation between average BOLD time series of DLPFC and ACC, computed per scanned participant and Fisher-z-transformed. Only participants who underwent fMRI are included.
Measurement tool: Resting-state fMRI on 3T MRI scanner; ROI time-series extraction and correlation analysis Unit of measure: Fisher-z (dimensionless) How aggregated: Mean Fisher-z per participant; Change score = Day 29 - Day 1.
Measured: Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).
Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between anterior cingulate cortex (ACC) and amygdala
Resting-state fMRI-based Pearson correlation between average BOLD time series of anterior cingulate cortex (ACC) and amygdala, Fisher-z-transformed.
Measurement tool: Resting-state fMRI on 3T MRI scanner; ROI time-series extraction and correlation analysis.
Unit of measure: Fisher-z (dimensionless) How aggregated: Mean Fisher-z per participant; Change score = Day 29 - Day 1.
Measured: Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).
Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between hippocampus and amygdala
Resting-state fMRI-based Pearson correlation between average BOLD time series of hippocampus and amygdala, Fisher-z-transformed.
Measurement tool: Resting-state fMRI on 3T MRI scanner; ROI time-series extraction and correlation analysis.
Unit of measure: Fisher-z (dimensionless) How aggregated: Mean Fisher-z per participant; Change score = Day 29 - Day 1.
Measured: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), and day 29 (after the full 4 weeks of treatment).
Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between dorsolateral prefrontal cortex (DLPFC) and hippocampus
Resting-state fMRI-based Pearson correlation between average BOLD time series of dorsolateral prefrontal cortex (DLPFC) and hippocampus, Fisher-z-transformed.
Measurement tool: Resting-state fMRI on 3T MRI scanner; ROI time-series extraction and correlation analysis.
Unit of measure: Fisher-z (dimensionless) How aggregated: Mean Fisher-z per participant; Change score = Day 29 - Day 1.
Measured: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), and day 29 (after the full 4 weeks of treatment).
Change in blood pressure (part of general physical health assessment)
Systolic blood pressure measured in mmHg. Values interpreted according to standard clinical reference ranges.
Measurement tool: Standard sphygmomanometer or automated BP monitor Unit of measure: mmHg How aggregated: Mean systolic BP per participant; Change score = current day - baseline
Measured: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), and day 29 (after the full 4 weeks of treatment).
Change in heart rate (part of general physical health assessment)
Description: Heart rate measured in beats per minute (bpm). Values interpreted according to standard clinical reference ranges.
Measurement tool: Pulse oximeter, ECG, or manual measurement Unit of measure: beats per minute (bpm) How aggregated: Mean heart rate per participant; Change score = current day - baseline.
Measured: Day 1 (baseline), Day 15 (after 2 weeks of treatment), Day 29 (after 4 weeks of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start15 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depression ModerateStudies of the same condition, open and under way.
- 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
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrike Vogelmann, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146269
- Sponsor's protocol ID
- RWNM_tDCS_VR
- Acronym
- VR-TMD
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymised study outcomes will be shared, including questionnaire, physiological, and device data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality-Based Relaxation as an Adjunctive Therapy to Optimize At-Home Transcranial Direct Current Stimulation (tDCS) for Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07146269
- Acronym / sponsor ID
- VR-TMD / RWNM_tDCS_VR
- Conditions
- Major Depression Moderate, Major Depression Severe
- Keywords
- Non-invasive Brain Stimulation (NIBS), Major Depression, Virtual Reality (VR), Transcranial Direct Current Stimulation (tDCS), tDCS at-home
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 28 Aug 2025 (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 goal of this clinical trial is to investigate the efficacy of combining Virtual Reality (VR)-based relaxation and Transcranial Direct Current Stimulation (tDCS) for treating Major Depression.
The main questions this study aims to answer are:
- Does the combination of VR Relaxation and tDCS at-home result in significantly greater symptom improvement in depression than tDCS alone?
- Are there differences in treatment effectiveness depending on demographic characteristics (e.g., age, gender)?
- Feasibility: What is the level of acceptance and adherence to the combined VR and tDCS therapy compared to tDCS alone?
In a randomized controlled trial, patients will be assigned to either a tDCS + VR group or a tDCS-only group.
The study protocol is the following:
- On the first day, patients complete baseline questionnaires and are then randomly assigned to either the tDCS-only group or the tDCS + VR group.
- Both groups perform home-based treatment five times per week for four weeks, with each session lasting 30 minutes.
- After two weeks, patients return for a follow-up visit to complete questionnaires and assess adherence, side effects, and clinical progress.
- At the end of the four-week treatment period, a final assessment is conducted, including questionnaires and patient feedback.
- After 12-16 weeks (i.e. 2 to 3 months after the last tDCS session) Follow Up Assessment (BDI, MADRS, HDRS, GCI, GAF)
Detailed description
Participant Recruitment:
Patients with unipolar or bipolar depression will be recruited from inpatient wards at Klinikum rechts der Isar and outpatient services. After screening for eligibility and obtaining informed consent, participants will be randomized into two groups (1:1), stratified by depression severity (MADRS > or < 30):
Active Group: 4-week home-based combination therapy of tDCS and VR-based relaxation
Control Group: 4-week home-based tDCS without VR relaxation
Treatment Protocol:
at-home tDCS: 2 mA for 30 minutes, electrodes at F3/F4 (bifrontal, over DLPFC), daily Monday to Friday, total 20 sessions. Optional MRI before/after treatment.
VR Relaxation: Nature exposure via VR headset, 30 minutes daily parallel to tDCS, Monday to Friday, 20 sessions.
Assessment Schedule:
Baseline Visit (Visit 1): Informed Consent, demographics, medical history, vital signs, and baseline scales (BDI, MADRS, HDRS, GCI, GAF, CTQ, EHI, FTND). First session in-clinic with training for home use. Up to 5 additional sessions may be conducted in-clinic.
Mid-Treatment (Visit 2): After 2 weeks: vital signs, questionnaires (BDI, MADRS, HDRS, GCI, GAF), therapy adherence (according to number of conducted sessions), side effects, treatment adjustments if needed.
Final Assessment (Visit 3): After 4 weeks: final vitals, questionnaires (BDI, MADRS, HDRS, GCI, GAF), patient satisfaction survey, therapy experience interview.
Follow Up Assessment (Visit 4): After 12-16 weeks: questionnaires (BDI, MADRS, HDRS, GCI, GAF)
Technical data on tDCS use (automatic logging) including time, adherence, etc., will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS only | Active comparator | Device: tDCSTranscranial Direct Current Stimulation (tDCS) at home, 20 sessions, 2mA (5 days/week, for 4 weeks) |
| tDCS plus VR | Experimental | Device: tDCS, Device: VR-based relaxation therapyTranscranial Direct Current Stimulation (tDCS) at home plus Virtual Reality (VR)-based relaxation 20 sessions, 2mA (5 days/week, for 4 weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least a moderate depressive episode (MADRS baseline score ≥ 20).
- Patients aged between 18 and 65 years.
- Sufficient cognitive abilities to understand study requirements and instructions (MMSE ≥ 27).
- Stable antidepressant/psychiatric medication for at least two weeks prior to study entry.
Key exclusion criteria (4 listed)
- Currently clinically relevant Axis II disorders.
- Other relevant Axis I disorders (except anxiety disorders).
- Substance use disorders within the last 3 months prior to study entry (excluding nicotine and caffeine dependence).
- Skin lesions at the site of tDCS electrode placement.
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 |
|---|---|---|
| tDCSTranscranial Direct Current Stimulation delivered at an intensity of 2 mA over electrodes at F3/F4 (bifrontal, over DLPFC), for 30 minutes a day, Monday to Friday, for a total 20 sessions. | Device | tDCS only, tDCS plus VR |
| VR-based relaxation therapyNature exposure via a Virtual Reality (VR) headset, for 30 minutes daily concurrently to tDCS, Monday to Friday, for a total of 20 sessions. | Device | tDCS plus VR |
Primary outcome
Depressive symptoms assessed by MADRS
Time frame: Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).
Major Depression psychiatric symptoms assessed with the Montgomery Asberg Depression Rating Scale (MADRS). MADRS values are interpreted as follows: 0-6 = No depression, 07-19 = mild, 20-34 = moderate, 35-60 = severe. Primary outcome is the Difference in MADRS Score from baseline to post-treatment visit (day 29)
10 secondary outcomes
Clinical Global Impression assessed by CGI-S
Time frame: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), day 29 (after the full 4 weeks of treatment) and followup in 2-3 Months (after 12-16 weeks of treatment).
Psychosocial functioning assessed by GAF score
Time frame: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), day 29 (after the full 4 weeks of treatment) and followup in 2-3 Months (after 12-16 weeks of treatment).
Depressive symptoms assessed by BDI-II
Time frame: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), day 29 (after the full 4 weeks of treatment) and followup in 2-3 Months (after 12-16 weeks of treatment).
Depressive symptoms assessed by HDRS
Time frame: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), day 29 (after the full 4 weeks of treatment) and followup in 2-3 Months (after 12-16 weeks of treatment).
Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between dorsolateral prefrontal cortex (DLPFC) and anterior cingulate cortex (ACC) in a subset of participants
Time frame: Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).
Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between anterior cingulate cortex (ACC) and amygdala
Time frame: Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).
Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between hippocampus and amygdala
Time frame: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), and day 29 (after the full 4 weeks of treatment).
Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between dorsolateral prefrontal cortex (DLPFC) and hippocampus
Time frame: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), and day 29 (after the full 4 weeks of treatment).
Change in blood pressure (part of general physical health assessment)
Time frame: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), and day 29 (after the full 4 weeks of treatment).
Change in heart rate (part of general physical health assessment)
Time frame: Day 1 (baseline), Day 15 (after 2 weeks of treatment), Day 29 (after 4 weeks of treatment)
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 28 Aug 2025.
- Individual participant dataSharing planned: Yes. All anonymised study outcomes will be shared, including questionnaire, physiological, and device data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and VR-based relaxation therapy in people with Major Depression Moderate and Major Depression Severe, run by Technical University of Munich at 1 site in Germany.
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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 28 Aug 2025. 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 Germany. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms assessed by MADRS (time frame: Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).). 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 28 Aug 2025.