Software Treatments for Actively Reducing Severity of Cognitive Deficits in MDD (STARS-MDD)

Completed · Not applicable

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT03310281

Run by

Akili Interactive Labs, Inc.

People needed

84

Starts

2017-12-04

Expected to finish

2018-11-14

Last updated by the study team

2018-11-21

Who can join

Age: 25 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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