N/A N=1,001 Randomized Quadruple-blind Treatment

The Effects of Videogames on Depression Symptoms and Brain Dynamics

Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT05426265 ↗

Enrolled (actual)

1,001

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: PHQ-9 Total Change From Baseline to Posttreatment: Experimental Group vs. Treatment as Usual Group — -1.941; -0.803 adjusted score change — p=0.0000022

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MEL-T01 (Device); MEL-S01 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aalto University
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY PHQ-9 Total Change From Baseline to Posttreatment: Experimental Group vs. Treatment as Usual Group	-1.941; -0.803	0.0000022 sig
PRIMARY PHQ-9 Total Change From Baseline to Posttreatment: Active Comparator Group vs. Treatment as Usual Group	-1.429; -0.803	0.006 sig
PRIMARY PHQ-9 Total Change From Baseline to Posttreatment: Experimental Group vs. Active Comparator Group	-1.941; -1.429	0.045 sig
SECONDARY QIDS Total Change From Baseline to Posttreatment	-1.810; -1.286; -0.688	0.012 sig
SECONDARY RRS (Short Version) Total Change From Baseline to Posttreatment	-1.073; -0.671; -0.904	0.048 sig
SECONDARY GAD-7 Total Change From Baseline to Posttreatment	-1.168; -0.706; -0.335	0.055
SECONDARY SDS Total Change From Baseline to Posttreatment	-1.663; -1.041; -0.272	0.071
SECONDARY PVSS Total Change From Baseline to Posttreatment	6.524; 6.952; -0.426	0.599
SECONDARY WHO-5 Total Change From Baseline to Posttreatment	1.148; 1.203; 0.156	0.603
SECONDARY Correlation Between PHQ-9 Total Change and Playing Time in Group MEL-T01	-0.126	0.696
SECONDARY Correlation Between PHQ-9 Total Change and Playing Time in Group MEL-S01	-0.300	0.333
SECONDARY Correlation Between PHQ-9 Total Change and IEQ in Group MEL-T01	-0.680	0.043 sig
SECONDARY Correlation Between PHQ-9 Total Change and IEQ in Group MEL-S01	-0.705	0.032 sig

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05426265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.