Clinical trial NCT03310281: Software Treatments for Actively Reducing Severity of Cognitive Deficits in MDD (STARS-MDD)
Official title: A Randomized, Double-blind, Controlled, 6-week Trial to Assess the Impact of Novel Digital Interventions Designed to Improve Cognitive Dysfunction as Adjunct Therapy to Antidepressant Medication in Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
Lead sponsor: Akili Interactive Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-16
Enrollment: 84
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of recurrent Major Depressive Disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by MINI Version 7.0.2.
* Pre-Screening (Day≤-28) Remote or In-Clinic
* Screening/Day 0 (in-clinic) including:
* HAM-D-17 score
* BAC Symbol Coding T-test score
* On stable antidepressant medication for ≥8 weeks prior to screening/baseline, with stable dose for ≥4 weeks prior to baseline/baseline, with or without stable adjunct psychotherapy (excluding DBT or CBT) for ≥12 weeks.
* Access to and self-report of ability to connect wireless devices to a functional wireless network
* Ability to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
* Normal color vision as tested by Ishihara Color Blindness Test
* Able to comply with all testing and requirements

Exclusion Criteria:

* Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms including but not limited to post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or anxiety disorder, conduct disorder, ADHD or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments.
* Initiation or completion of psychotherapy within the last 12 weeks prior to screening/baseline. The participant should inform the Investigator if they intend to change their psychotherapy during the 6 weeks of the study. Participants who have been in psychotherapy consistently for more than 12 weeks may participate if their routine is stable throughout the study.
* Participant is currently considered at risk for attempting suicide by the Investigator, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior, as measured by CSSRS.
* Motor condition (e.g. physical deformity of the hands/arms) that prevents game playing as reported by the participant or observed by the Investigator.
* Recent history (6 months prior to screening/baseline) of substance use disorder
* History of seizures (excluding febrile seizures), a tic disorder, significant tics, a current diagnosis of Tourette's Disorder.
* Self-report of recent episodes (within the past week) of nausea, vomiting and/or dizziness.
* Participation in a clinical trial within 3 months prior to screening.
* Color blindness as detected by Ishihara Color Blindness Test
* Regular use of psychoactive drugs other than antidepressants, including stimulants that in the opinion of the Investigator may confound study data/assessments.
* Use of benzodiazepines \>3 times per week and/or within 24 hours of baseline and exit visit assessments prohibited.
* Use of marijuana or alcohol on the day of clinical visits before baseline or exit assessments, no tobacco within 30 minutes of TOVA
* Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
* Previous exposure to Akili products.
* Another household member who is/has participated in this trial

Primary outcomes:
measure: Change in reaction time to rare target stimuli, from the Test of Variables of Attention (TOVA)
timeFrame: Study Day 0 to Study Day 42
Secondary outcomes:
measure: Change in the cognitive component sub-score (items 4-7) of the Cognitive and Physical Functioning Questionnaire (CPFQ)
timeFrame: Study Day 0 to Study Day 42
measure: Change in Patient Deficit Questionnaire (PDQ) score
timeFrame: Study Day 0 to Study Day 42
measure: Change in Letter Number Span (LNS) working memory test score
timeFrame: Study Day 0 to Study Day 42
measure: Change in Stroop color and words test score
timeFrame: Study Day 0 to Study Day 42
measure: Change in Trail-making tests A and B scores
timeFrame: Study Day 0 to Study Day 42
measure: Change in BAC Symbol Coding Test score
timeFrame: Study Day 0 to Study Day 42
measure: Change in Trait Adjective Task score
timeFrame: Study Day 0 to Study Day 42
Other outcomes:
measure: Exploratory Outcome Measure: Change in Hamilton Depression Scale HAM-D_17 (6 depression-focused subset)
timeFrame: Study Day 0 to Study Day 42
measure: Exploratory Outcome Measure: Change in Patient Health Questionnaire 9 (PHQ-9) score
timeFrame: Study Day 0 to Study Day 42
measure: Exploratory Outcome Measure: Change in Clinical Global Impression Severity and Improvement Scale (CGI-I and CGI-S) scores
timeFrame: Study Day 0 to Study Day 42
measure: Exploratory Outcome Measure: Change in Cognitive and Physical Functioning Questionnaire (CPFQ) total scores
timeFrame: Study Day 0 to Study Day 42
measure: Exploratory Outcome Measure: Change in Patient Deficit Questionnaire (PDQ) score
timeFrame: Study Day 0 to Study Day 42
measure: Exploratory Outcome Measure: Change in Test of Variable of Attention (TOVA) Attention Performance Index (API)
timeFrame: Study Day 0 to Study Day 42
measure: Exploratory Outcome Measure: Change in Quality of Life, Enjoyment and satisfaction Questionnaire - Global Function (Q-LES-Q) scores
timeFrame: Study Day 0 to Study Day 42
measure: Exploratory Outcome Measure: Change in Work & Social Adjustment Scale (WSAS) score
timeFrame: Study Day 0 to Study Day 42
measure: Exploratory Outcome Measure: Change in Emotional Regulation Questionnaire (ERQ) score
timeFrame: Study Day 0 to Study Day 42
measure: Exploratory Outcome Measure: Change in Difficulty in Emotional Regulation Scale (DERS) score
timeFrame: Study Day 0 to Study Day 42
Locations:
city: Garden Grove
country: United States
facility: CNS Network, Inc.
state: California
city: North Miami
country: United States
facility: Behavioral Clinical Research, Inc.
state: Florida
city: North Miami
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Charleston
country: United States
facility: Segal Trials
state: North Carolina
Study officials:
affiliation: Duke Institute for Brain Sciences
name: Richard Keefe, PhD
role: PRINCIPAL_INVESTIGATOR
References: