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

NCT03310281 | Completed

• 1 other identifier: Akili-035
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 4

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.

Conditions

Major Depressive Disorder

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  Study Day 0 to Study Day 42

Secondary Outcomes (7)

• Change in the cognitive component sub-score (items 4-7) of the Cognitive and Physical Functioning Questionnaire (CPFQ)

  Study Day 0 to Study Day 42

• Change in Patient Deficit Questionnaire (PDQ) score

  Study Day 0 to Study Day 42

• Change in Letter Number Span (LNS) working memory test score

  Study Day 0 to Study Day 42

• Change in Stroop color and words test score

  Study Day 0 to Study Day 42

• Change in Trail-making tests A and B scores

  Study Day 0 to Study Day 42

Other Outcomes (10)

• Exploratory Outcome Measure: Change in Hamilton Depression Scale HAM-D_17 (6 depression-focused subset)

  Study Day 0 to Study Day 42

• Exploratory Outcome Measure: Change in Patient Health Questionnaire 9 (PHQ-9) score

  Study Day 0 to Study Day 42

• Exploratory Outcome Measure: Change in Clinical Global Impression Severity and Improvement Scale (CGI-I and CGI-S) scores

  Study Day 0 to Study Day 42

Study Arms (2)

ALK-T03

ACTIVE COMPARATOR

AKL-T03 is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.

Device: HOLD: Videogame

AKL-T09

ACTIVE COMPARATOR

AKL-T09 is a digital intervention that requires the subject to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time.

Device: HOLD: Videogame

Interventions

HOLD: Videogame DEVICE

Videogame-like digital therapy

AKL-T09; ALK-T03

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Akili Interactive Labs, Inc.: lead

Study Sites (4)

CNS Network, Inc.

Garden Grove, California, 92845, United States

Location

Behavioral Clinical Research, Inc.

North Miami, Florida, 33161, United States

Location

Innovative Clinical Research, Inc.

North Miami, Florida, 33163, United States

Location

Segal Trials

Charleston, North Carolina, 29407, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Richard Keefe, PhD

  Duke Institute for Brain Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 16, 2017
• Study Start: December 4, 2017
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: November 21, 2018

Record last verified: 2018-11

Locations

US (4)