Major Depressive DisorderNCT05426265
The Effects of Videogames on Depression Symptoms and Brain Dynamics
A study testing MEL-T01 and MEL-S01 in people with Major Depressive Disorder, run by Aalto University at 6 sites in Finland.
Trial summary
The purpose of the study is to evaluate the effects of a game-based digital-therapeutics (DTx) medical software device on the symptoms of depression in adults with confirmed major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- MEL-T01 and MEL-S01
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,001 participants
- Where
- 6 sitesFinland
- Study dates
- 28 Jun 2022to 14 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18-65 year-old
- Suffering from major depressive disorder
- Have an ongoing mental health treatment contact to basic healthcare, specialised healthcare, student healthcare or occupational healthcare
- Has sufficient eyesight with or without prescription
- Has a Windows computer with internet connection and mouse
- Has email and phone number
Who cannot join
- They have threat of self-harm
- They have addiction to digital games
- They have psychotic disorders
- They are pregnant or breastfeeding
- They have impaired ability in decision making
- They are prisoner or forensic subject
- They have neurological disorders such as epilepsy or brain injury
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Finland6 sites
Aalto University (TMS)
Espoo, Uusimaa, 02150
Aalto University, Department of Neuroscience and Biomedical Engineering
Espoo, Uusimaa, 02150
Helsinki University Hospital, Psychiatry
Helsinki, Uusimaa, 00014
Helsinki University Hospital BioMag laboratory
Helsinki, Uusimaa, 00029
University of Helsinki Neuroscience Center (MEG, MRI)
Helsinki, Uusimaa
Turku University Hospital
Turku, Southwest Finland, 20521
About this study
The purpose of the study is to evaluate the effects of a game-based digital-therapeutics (DTx) medical software device on the symptoms of depression in adults with confirmed major depressive disorder.
Read the detailed description
The study is a comparator-controlled, randomised, double-blinded intervention study aimed at assessing the effects of the investigational device MEL-T01, "Meliora", on the symptoms of major depressive disorder (MDD). MEL-S01 acts as a comparator. MEL-T01 is a game-based digital-therapeutics (DTx) medical software device developed at Aalto University and is intended to be used as a treatment for MDD together with treatment-as-usual (TAU). MEL-T01 implements personalised cognitive training to alleviate MDD symptoms and improve cognitive performance in MDD subjects.
Subjects volunteering to participate in this investigation are adults whose MDD is confirmed through MINI interview. They have an on-going mental health treatment contact with a mental health professional. The subjects are randomised into three arms with equal probabilities in blocks of six consecutive subjects. Subjects in the MEL-T01 and MEL-S01 arms are engaged in the intervention for 12 weeks while those in the TAU arm are on a follow-up period during these 12 weeks. After this 12-week period, the subjects in MEL-T01 and MEL-S01 arms enter a 12-week follow-up period and the subjects in TAU arm engage with either the MEL-T01 or MEL-S01 intervention (randomised at T0 with equal probability) for 12 weeks.
The subjects are recommended to play the investigational-device game for a total of 48 hours during the 12 weeks of active intervention with a recommended weekly dose of 4 hours. A minimum of 24 hours is needed for inclusion to hypothesis testing. The subjects are limited to a daily maximum of 1.5 hours of game time.
The subjects' mental health symptoms and well-being are evaluated through online questionnaires five times: before subjects are randomised into one of the three groups (T0), and then 4 (T1), 8 (T2), 12 (T3), and 24 (T4) weeks after the study has begun.
- Conditions
- Major Depressive Disorder
- Being tested
- MEL-T01, MEL-S01
- Keywords
- Depression, Digital therapeutics, Digital mental health intervention
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEL-T01Device
Also called Meliora
A 12 week intervention with MEL-T01.
MEL-S01Device
A 12 week intervention with MEL-S01.
| Study group | Role | What they receive |
|---|---|---|
| MEL-T01 | Experimental | MEL-T01 is a game-based digital-therapeutics (DTx) medical software device that implements personalised cognitive training to alleviate MDD symptoms and improve cognitive performance in MDD subjects. Receives: Device: MEL-T01 |
| MEL-S01 | Active comparator | MEL-S01 is an active comparator similar to MEL-T01 but without personalized cognitive training elements. Receives: Device: MEL-S01 |
| TAU | No intervention | Treatment-as-usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-9 Total Change From Baseline to Posttreatment: Experimental Group vs. Treatment as Usual Group
The patient health questionnaire (PHQ-9, Kroenke et al., 2001) is a self-report measure of major depressive disorder. The PHQ-9 scores each of the nine DSM-IV criteria for MDD from "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score of depression. The higher the total score the more severe the depression.
The change in the PHQ-9 total score between before the 12 week intervention and after the intervention is measured. The change score of MEL-T01 group is compared with the change score of the treatment-as-usual (TAU) group.
Measured: Day 0 to Day 84
PHQ-9 Total Change From Baseline to Posttreatment: Active Comparator Group vs. Treatment as Usual Group
The patient health questionnaire (PHQ-9, Kroenke et al., 2001) is a self-report measure of major depressive disorder. The PHQ-9 scores each of the nine DSM-IV criteria for MDD from "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score of depression. The higher the total score the more severe the depression.
The change in the PHQ-9 total score between before the 12 week intervention and after the intervention is measured. The change score of MEL-S01 group is compared with the change score of the treatment-as-usual (TAU) group.
Measured: Day 0 to Day 84
PHQ-9 Total Change From Baseline to Posttreatment: Experimental Group vs. Active Comparator Group
The patient health questionnaire (PHQ-9, Kroenke et al., 2001) is a self-report measure of major depressive disorder. The PHQ-9 scores each of the nine DSM-IV criteria for MDD from "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score of depression. The higher the total score the more severe the depression.
The change in the PHQ-9 total score between before the 12 week intervention and after the intervention is measured. The change score of MEL-T01 group is compared with the change score in the MEL-S01 group.
Measured: Day 0 to Day 84
Secondary outcomes (10)
QIDS Total Change From Baseline to Posttreatment
The quick inventory of depressive symptomatology (QIDS-SR16) is a self-report measure comprising of 16 questions on a scale of 0-3 which assess the severity of depressive symptoms. The inventory provides a total score between 0 and 48: the higher the total score the more severe the depression.
For each of the three study arms, the change in total QIDS-SR16 scores between before the intervention and after the 12 week intervention is measured. Then, the average change scores in each of the three groups are compared with each other.
Measured: Day 0 to Day 84
RRS (Short Version) Total Change From Baseline to Posttreatment
Ruminative Response Scale (RRS), short version, is an eight item self-report questionnaire that uses a four point Likert-scale. This leads to a total score between 8 and 64 where higher values indicate higher depressive brooding.
For each of the three study arms, the change in total RRS scores between before the intervention compared and after the 12 week intervention are measured. Then, the average change scores in each of the three groups are compared with each other.
Measured: Day 0 to Day 84
GAD-7 Total Change From Baseline to Posttreatment
The general anxiety disorder scale (GAD-7) is a seven-item self-report questionnaire that uses a 4-point scale (between 0 and 3) to evaluate the degree of anxiety symptoms. The questionnaire provides a total between 0 and 21: the higher the total score, the more severe the anxiety.
For each of the three study arms, the change in total GAD-7 scores between before the intervention and after the 12 week intervention is measured. Then, the average change scores in each of the three groups are compared with each other.
Measured: Day 0 to Day 84
SDS Total Change From Baseline to Posttreatment
The Sheehan disability scale (SDS) is a self-administered three item questionnaire using a 11-point scale (between 0 and 10). The scale is used to measure functional impairment. The scale provides a total score between 0 and 30: the higher the score, the higher the functional impairment. In addition, the scale measures "the number of days lost to symptoms" and "the number of days unproductive due to the symptoms".
For each of the three study arms, the change in total SDS scores between before the intervention and after the 12 week intervention is measured. Then, the average change scores in each of the three groups are compared with each other.
Measured: Day 0 to Day 84
PVSS Total Change From Baseline to Posttreatment
The positive valence systems scale (PVSS) is a 21-item self-report questionnaire using a scale from 1 to 9. This leads to a total score between 21 and 189 where a lower total score indicates higher anhedonia.
For each of the three study arms, the change in total PVSS scores between before the intervention and after the 12 week intervention is measured. Then, the average change scores in each of the three groups are compared with each other.
Measured: Day 0 to Day 84
WHO-5 Total Change From Baseline to Posttreatment
The well-being index (WHO-5) is a five item self-report questionnaire using a scale from 0 to 5. This leads to a total score is between 0 and 25: higher scores indicate higher subjective well-being.
For each of the three study arms, the change in total WHO-5 scores between before the intervention and after the 12 week intervention is measured. Then, the average change scores in each of the three groups are compared with each other.
Measured: Day 0 to Day 84
Correlation Between PHQ-9 Total Change and Playing Time in Group MEL-T01
The patient health questionnaire (PHQ-9, Kroenke et al., 2001) is a self-report measure of major depressive disorder. The PHQ-9 scores each of the nine DSM-IV criteria for MDD from "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score of depression. The higher the total score the more severe the depression.
For the treatment MEL-T01 group, the change scores in the total PHQ-9 score between before the intervention and after the 12 week intervention is measured. Then, the correlation between the change score and the minutes played during the intervention is calculated. This leads to a correlation score that evaluates whether a higher symptom change is associated with higher playing time.
Measured: Day 0 to Day 84
Correlation Between PHQ-9 Total Change and Playing Time in Group MEL-S01
The patient health questionnaire (PHQ-9, Kroenke et al., 2001) is a self-report measure of major depressive disorder. The PHQ-9 scores each of the nine DSM-IV criteria for MDD from "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score of depression. The higher the total score the more severe the depression.
For the active comparator MEL-S01 group, the change scores in the total PHQ-9 score between before the intervention and after the 12 week intervention is measured. Then, the correlation between the change score and the minutes played during the intervention is calculated. This leads to a correlation score that evaluates whether a higher symptom change is associated with higher playing time.
Measured: Day 0 to Day 84
Correlation Between PHQ-9 Total Change and IEQ in Group MEL-T01
The immersive experiences questionnaire (IEQ, Jennett et al., 2008) is a self-report questionnaire that measures the subjective experience of being immersed while playing a video game. It has 31 questions on a scale of 1-7. This creates a total score between 31 and 217: the higher totals indicate higher immersion. In addition, there is one question - "How immersed did you feel?" - on a scale of 1-10.
For the treatment MEL-T01 group, we measure the correlation between 1) the change in the total PHQ-9 score between before the intervention and after the 12 week intervention and 2) the total IEQ score (excluding the one additional questionnaire) as measured after the 12 week intervention.
This leads to a correlation score that evaluates whether a higher symptom change is associated with higher immersion in the game.
Measured: Day 0 to Day 84
Correlation Between PHQ-9 Total Change and IEQ in Group MEL-S01
The immersive experiences questionnaire (IEQ, Jennett et al., 2008) is a self-report questionnaire that measures the subjective experience of being immersed while playing a video game. It has 31 questions on a scale of 1-7. This creates a total score between 31 and 217: the higher totals indicate higher immersion. In addition, there is one question - "How immersed did you feel?" - on a scale of 1-10.
For the treatment MEL-S01 group, we measure the correlation between 1) the change in the total PHQ-9 score between before the intervention and after the 12 week intervention and 2) the total IEQ score (excluding the one additional questionnaire) as measured after the 12 week intervention.
This leads to a correlation score that evaluates whether a higher symptom change is associated with higher immersion in the game.
Measured: Day 0 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start28 Jun 2022
- Primary completion14 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Model description
- The effectiveness of MEL-T01 and comparator MEL-S01 are studied. Their effectiveness is compared to a treatment-as-usual (TAU) group who also receive the intervention after a 12 week waiting period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalto University
- Sponsor type
- University, hospital or other
- Collaborators
- Business Finland, Helsinki University Central Hospital, Turku University Hospital
- Responsible party
- Sponsor
- Investigators
- Hanna Renvall, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426265
- Sponsor's protocol ID
- MelioraRCT
- Status last verified
- Apr 2026
- First submitted
- 17 May 2022
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lukka L, Vesterinen M, Salonen A, Bergman VR, Torkki P, Palva S, Palva JM. User journey method: a case study for improving digital intervention use measurement. BMC Health Serv Res. 2025 Apr 1;25(1):479. doi: 10.1186/s12913-025-12641-9.
PubMed 40165237
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Videogames on Depression Symptoms and Brain Dynamics
- ClinicalTrials.gov ID
- NCT05426265
- Acronym / sponsor ID
- MelioraRCT
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Digital therapeutics, Digital mental health intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Aalto UniversityUniversity, hospital or other
- Collaborators
- Business Finland, Helsinki University Central Hospital, Turku University Hospital
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the effects of a game-based digital-therapeutics (DTx) medical software device on the symptoms of depression in adults with confirmed major depressive disorder.
Detailed description
The study is a comparator-controlled, randomised, double-blinded intervention study aimed at assessing the effects of the investigational device MEL-T01, "Meliora", on the symptoms of major depressive disorder (MDD). MEL-S01 acts as a comparator. MEL-T01 is a game-based digital-therapeutics (DTx) medical software device developed at Aalto University and is intended to be used as a treatment for MDD together with treatment-as-usual (TAU). MEL-T01 implements personalised cognitive training to alleviate MDD symptoms and improve cognitive performance in MDD subjects.
Subjects volunteering to participate in this investigation are adults whose MDD is confirmed through MINI interview. They have an on-going mental health treatment contact with a mental health professional. The subjects are randomised into three arms with equal probabilities in blocks of six consecutive subjects. Subjects in the MEL-T01 and MEL-S01 arms are engaged in the intervention for 12 weeks while those in the TAU arm are on a follow-up period during these 12 weeks. After this 12-week period, the subjects in MEL-T01 and MEL-S01 arms enter a 12-week follow-up period and the subjects in TAU arm engage with either the MEL-T01 or MEL-S01 intervention (randomised at T0 with equal probability) for 12 weeks.
The subjects are recommended to play the investigational-device game for a total of 48 hours during the 12 weeks of active intervention with a recommended weekly dose of 4 hours. A minimum of 24 hours is needed for inclusion to hypothesis testing. The subjects are limited to a daily maximum of 1.5 hours of game time.
The subjects' mental health symptoms and well-being are evaluated through online questionnaires five times: before subjects are randomised into one of the three groups (T0), and then 4 (T1), 8 (T2), 12 (T3), and 24 (T4) weeks after the study has begun.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The effectiveness of MEL-T01 and comparator MEL-S01 are studied. Their effectiveness is compared to a treatment-as-usual (TAU) group who also receive the intervention after a 12 week waiting period.
| Arm | Type | Receives |
|---|---|---|
| MEL-T01 | Experimental | Device: MEL-T01MEL-T01 is a game-based digital-therapeutics (DTx) medical software device that implements personalised cognitive training to alleviate MDD symptoms and improve cognitive performance in MDD subjects. |
| MEL-S01 | Active comparator | Device: MEL-S01MEL-S01 is an active comparator similar to MEL-T01 but without personalized cognitive training elements. |
| TAU | No intervention | –Treatment-as-usual. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between 18-65 year-old
- Suffering from major depressive disorder
- Have an ongoing mental health treatment contact to basic healthcare, specialised healthcare, student healthcare or occupational healthcare
- Has sufficient eyesight with or without prescription
- Has a Windows computer with internet connection and mouse
Key exclusion criteria (7 listed)
- They have threat of self-harm
- They have addiction to digital games
- They have psychotic disorders
- They are pregnant or breastfeeding
- They have impaired ability in decision making
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 |
|---|---|---|
| MEL-T01Also: MelioraA 12 week intervention with MEL-T01. | Device | MEL-T01 |
| MEL-S01A 12 week intervention with MEL-S01. | Device | MEL-S01 |
Primary outcome
PHQ-9 Total Change From Baseline to Posttreatment: Experimental Group vs. Treatment as Usual Group
Time frame: Day 0 to Day 84
The patient health questionnaire (PHQ-9, Kroenke et al., 2001) is a self-report measure of major depressive disorder. The PHQ-9 scores each of the nine DSM-IV criteria for MDD from "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score of depression. The higher the total score the more severe the depression. The change in the PHQ-9 total score between before the 12 week intervention and after the intervention is measured. The change score of MEL-T01 group is compared with the change score of the treatment-as-usual (TAU) group.
PHQ-9 Total Change From Baseline to Posttreatment: Active Comparator Group vs. Treatment as Usual Group
Time frame: Day 0 to Day 84
The patient health questionnaire (PHQ-9, Kroenke et al., 2001) is a self-report measure of major depressive disorder. The PHQ-9 scores each of the nine DSM-IV criteria for MDD from "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score of depression. The higher the total score the more severe the depression. The change in the PHQ-9 total score between before the 12 week intervention and after the intervention is measured. The change score of MEL-S01 group is compared with the change score of the treatment-as-usual (TAU) group.
PHQ-9 Total Change From Baseline to Posttreatment: Experimental Group vs. Active Comparator Group
Time frame: Day 0 to Day 84
The patient health questionnaire (PHQ-9, Kroenke et al., 2001) is a self-report measure of major depressive disorder. The PHQ-9 scores each of the nine DSM-IV criteria for MDD from "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score of depression. The higher the total score the more severe the depression. The change in the PHQ-9 total score between before the 12 week intervention and after the intervention is measured. The change score of MEL-T01 group is compared with the change score in the MEL-S01 group.
10 secondary outcomes
QIDS Total Change From Baseline to Posttreatment
Time frame: Day 0 to Day 84
RRS (Short Version) Total Change From Baseline to Posttreatment
Time frame: Day 0 to Day 84
GAD-7 Total Change From Baseline to Posttreatment
Time frame: Day 0 to Day 84
SDS Total Change From Baseline to Posttreatment
Time frame: Day 0 to Day 84
PVSS Total Change From Baseline to Posttreatment
Time frame: Day 0 to Day 84
WHO-5 Total Change From Baseline to Posttreatment
Time frame: Day 0 to Day 84
Correlation Between PHQ-9 Total Change and Playing Time in Group MEL-T01
Time frame: Day 0 to Day 84
Correlation Between PHQ-9 Total Change and Playing Time in Group MEL-S01
Time frame: Day 0 to Day 84
Correlation Between PHQ-9 Total Change and IEQ in Group MEL-T01
Time frame: Day 0 to Day 84
Correlation Between PHQ-9 Total Change and IEQ in Group MEL-S01
Time frame: Day 0 to Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40165237Lukka L, Vesterinen M, Salonen A, Bergman VR, Torkki P, Palva S, Palva JM. User journey method: a case study for improving digital intervention use measurement. BMC Health Serv Res. 2025 Apr 1;25(1):479. doi: 10.1186/s12913-025-12641-9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hanna Renvall, PhD principal investigator
Helsinki University Central Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEL-T01 and MEL-S01 in people with Major Depressive Disorder, run by Aalto University at 6 sites in Finland.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PHQ-9 Total Change From Baseline to Posttreatment: Experimental Group vs. Treatment as Usual Group (time frame: Day 0 to Day 84). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05426265, which also lists 1 linked publication.
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 29 Apr 2026.