The purpose of this study is to evaluate the effects of videogame-like digital therapies as adjunct therapy to antidepressant medications on cognitive deficits associated with major depressive disorder.
The study will be a randomized, parallel group, controlled trial of two videogame-like (iPad-based) digital therapies. The study will consist of 3 primary phases: Pre-screening, Baseline, and Treatment. During the Pre-screening Phase (Day -28 to Day 0), participants will undergo pre-screening to evaluate eligibility for the study. Pre-screening may take place up to 28 days before the Baseline Visit (Day 0). Pre-screening may take place either over the phone, or in the clinic. On Day 0, the Baseline visit will occur wherein additional eligibility criteria will be established. The Treatment Phase (Day 1 to Day 42) will involve using the digital therapy at home for each participant followed by an In-Clinic assessment on Day 42 to assess key outcomes. During the Treatment Phase participants will be instructed to play their videogame-like intervention for approximately 25 minutes per day for 5 days per week. Compliance with treatment/use requirements will be monitored remotely during this phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Videogame-like digital therapy
CNS Network, Inc.
Garden Grove, California, United States
Behavioral Clinical Research, Inc.
North Miami, Florida, United States
Innovative Clinical Research, Inc.
North Miami, Florida, United States
Segal Trials
Charleston, North Carolina, United States
Change in reaction time to rare target stimuli, from the Test of Variables of Attention (TOVA)
Compare scores from the first half of the TOVA measured at DAY0/baseline with scores from the first half of the TOVA measured at DAY42/exit between the two treatment groups.
Time frame: Study Day 0 to Study Day 42
Change in the cognitive component sub-score (items 4-7) of the Cognitive and Physical Functioning Questionnaire (CPFQ)
Compare cognitive component (items 4-7) of CPFQ scores at DAY0/baseline to (items 4-7) of CPFQ scores at Day42/exit between the two treatment groups
Time frame: Study Day 0 to Study Day 42
Change in Patient Deficit Questionnaire (PDQ) score
Time frame: Study Day 0 to Study Day 42
Change in Letter Number Span (LNS) working memory test score
Time frame: Study Day 0 to Study Day 42
Change in Stroop color and words test score
Time frame: Study Day 0 to Study Day 42
Change in Trail-making tests A and B scores
Time frame: Study Day 0 to Study Day 42
Change in BAC Symbol Coding Test score
Time frame: Study Day 0 to Study Day 42
Change in Trait Adjective Task score
Time frame: Study Day 0 to Study Day 42
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