Status:
COMPLETED
Software Treatments for Actively Reducing Severity of Cognitive Deficits in MDD (STARS-MDD)
Lead Sponsor:
Akili Interactive Labs, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
25-55 years
Phase:
NA
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 disorde...
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 Treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2018
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03310281
Start Date
December 4 2017
End Date
November 14 2018
Last Update
November 21 2018
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
CNS Network, Inc.
Garden Grove, California, United States, 92845
2
Behavioral Clinical Research, Inc.
North Miami, Florida, United States, 33161
3
Innovative Clinical Research, Inc.
North Miami, Florida, United States, 33163
4
Segal Trials
Charleston, North Carolina, United States, 29407