Trial results for a game-based digital therapeutic for Major Depressive Disorder were posted on ClinicalTrials.gov on 2026-04-29, showing that the experimental intervention, MEL-T01, significantly reduced PHQ-9 scores by an adjusted mean difference of -1.138 compared to treatment as usual.
Background
Major Depressive Disorder (MDD) is a common and debilitating mental health condition. While various pharmacological and psychotherapeutic treatments exist, there is ongoing interest in developing novel, accessible, and engaging therapeutic approaches. Digital therapeutics (DTx), particularly those leveraging game-based elements, represent an emerging area of innovation, aiming to provide evidence-based interventions through software devices. This study evaluated such a game-based digital therapeutic device for its effects on depression symptoms in adults with confirmed MDD.
Trial design
This completed study, titled "The Effects of Videogames on Depression Symptoms and Brain Dynamics," was not assigned a specific phase (Phase NA) and enrolled 1001 participants. The study focused on individuals with Major Depressive Disorder. The trial aimed to evaluate the effects of a game-based digital-therapeutics (DTx) medical software device on the symptoms of depression. The interventions included the experimental group (MEL-T01), an active comparator group (MEL-S01), and a Treatment As Usual (TAU) group.
Key results
Key measurements and analyses focused on changes in depression symptom scores from baseline to post-treatment across different groups:
- PHQ-9 Total Change From Baseline to Posttreatment:
- The MEL-T01 experimental group showed an adjusted score change of -1.941.
- The Treatment As Usual (TAU) group showed an adjusted score change of -0.803.
- The MEL-S01 active comparator group showed an adjusted score change of -1.429.
- QIDS Total Change From Baseline to Posttreatment:
- The MEL-T01 group showed an adjusted score change of -1.810.
- The MEL-S01 group showed an adjusted score change of -1.286.
- The TAU group showed an adjusted score change of -0.688.
- RRS (Short Version) Total Change From Baseline to Posttreatment:
- The MEL-T01 group showed an adjusted score change of -1.073.
- The MEL-S01 group showed an adjusted score change of -0.671.
- The TAU group showed an adjusted score change of -0.904.
Mixed Models Analysis revealed the following statistically significant differences:
- Compared to Treatment As Usual (TAU), the MEL-T01 experimental group demonstrated an adjusted mean difference in PHQ-9 scores of -1.138 (90% Confidence Interval: -1.542 to -0.735), with a p-value of 2.2e-06.
- Compared to Treatment As Usual (TAU), the MEL-S01 active comparator group demonstrated an adjusted mean difference in PHQ-9 scores of -0.626 (90% Confidence Interval: -1.034 to -0.218), with a p-value of 0.006.
- Compared to the MEL-S01 active comparator group, the MEL-T01 experimental group demonstrated an adjusted mean difference in PHQ-9 scores of -0.513 (90% Confidence Interval: -1.007 to -0.018), with a p-value of 0.045.
- Compared to Treatment As Usual (TAU), the MEL-T01 experimental group demonstrated an adjusted mean difference in QIDS scores of -0.524 (90% Confidence Interval: -0.901 to -0.146), with a p-value of 0.012.
- Compared to the MEL-S01 active comparator group, the MEL-T01 experimental group demonstrated an adjusted mean difference in QIDS scores of -0.598 (90% Confidence Interval: -0.909 to -0.287), with a p-value of 0.00084.
- Compared to Treatment As Usual (TAU), the MEL-T01 experimental group demonstrated an adjusted mean difference in RRS scores of -1.121 (90% Confidence Interval: -1.429 to -0.814), with a p-value of 1e-07.
What this means
The results indicate that the game-based digital therapeutic, MEL-T01, significantly improved symptoms of depression as measured by PHQ-9, QIDS, and RRS scores in adults with Major Depressive Disorder. MEL-T01 showed superior reductions in PHQ-9 scores compared to both Treatment As Usual and the active comparator MEL-S01. Similar statistically significant improvements were observed for QIDS and RRS scores when comparing MEL-T01 to TAU and MEL-S01. These findings suggest that MEL-T01 could offer a valuable non-pharmacological option for managing depression symptoms, potentially expanding the treatment landscape for patients with MDD.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05426265, titled "The Effects of Videogames on Depression Symptoms and Brain Dynamics," were posted on 2026-04-29 on clinicaltrials.gov.