ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 29 for:    STARS | Depression

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03310281
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Akili Interactive Labs, Inc.

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: HOLD: Videogame Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : October 15, 2018
Estimated Study Completion Date : November 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ALK-T03
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
Videogame-like digital therapy

Active Comparator: AKL-T09
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
Videogame-like digital therapy




Primary Outcome Measures :
  1. Change in reaction time to rare target stimuli, from the Test of Variables of Attention (TOVA) [ Time Frame: Study Day 0 to Study Day 42 ]
    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.


Secondary Outcome Measures :
  1. Change in the cognitive component sub-score (items 4-7) of the Cognitive and Physical Functioning Questionnaire (CPFQ) [ Time Frame: Study Day 0 to Study Day 42 ]
    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

  2. Change in Patient Deficit Questionnaire (PDQ) score [ Time Frame: Study Day 0 to Study Day 42 ]
  3. Change in Letter Number Span (LNS) working memory test score [ Time Frame: Study Day 0 to Study Day 42 ]
  4. Change in Stroop color and words test score [ Time Frame: Study Day 0 to Study Day 42 ]
  5. Change in Trail-making tests A and B scores [ Time Frame: Study Day 0 to Study Day 42 ]
  6. Change in BAC Symbol Coding Test score [ Time Frame: Study Day 0 to Study Day 42 ]
  7. Change in Trait Adjective Task score [ Time Frame: Study Day 0 to Study Day 42 ]

Other Outcome Measures:
  1. Exploratory Outcome Measure: Change in Hamilton Depression Scale HAM-D_17 (6 depression-focused subset) [ Time Frame: Study Day 0 to Study Day 42 ]
  2. Exploratory Outcome Measure: Change in Patient Health Questionnaire 9 (PHQ-9) score [ Time Frame: Study Day 0 to Study Day 42 ]
  3. Exploratory Outcome Measure: Change in Clinical Global Impression Severity and Improvement Scale (CGI-I and CGI-S) scores [ Time Frame: Study Day 0 to Study Day 42 ]
  4. Exploratory Outcome Measure: Change in Cognitive and Physical Functioning Questionnaire (CPFQ) total scores [ Time Frame: Study Day 0 to Study Day 42 ]
  5. Exploratory Outcome Measure: Change in Patient Deficit Questionnaire (PDQ) score [ Time Frame: Study Day 0 to Study Day 42 ]
  6. Exploratory Outcome Measure: Change in Test of Variable of Attention (TOVA) Attention Performance Index (API) [ Time Frame: Study Day 0 to Study Day 42 ]
  7. Exploratory Outcome Measure: Change in Quality of Life, Enjoyment and satisfaction Questionnaire - Global Function (Q-LES-Q) scores [ Time Frame: Study Day 0 to Study Day 42 ]
  8. Exploratory Outcome Measure: Change in Work & Social Adjustment Scale (WSAS) score [ Time Frame: Study Day 0 to Study Day 42 ]
  9. Exploratory Outcome Measure: Change in Emotional Regulation Questionnaire (ERQ) score [ Time Frame: Study Day 0 to Study Day 42 ]
  10. Exploratory Outcome Measure: Change in Difficulty in Emotional Regulation Scale (DERS) score [ Time Frame: Study Day 0 to Study Day 42 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310281


Contacts
Contact: Natalia Escuti, MD 818 481 2248 natalia.escuti@precisionformedicine.com

Locations
United States, California
CNS Network, Inc. Recruiting
Garden Grove, California, United States, 92845
Contact: Kathleen Catabay    714-799-7799 ext 2236    KathleenCatabay@cnstrial.com   
Principal Investigator: David Walling, PhD         
United States, Florida
Behavioral Clinical Research, Inc. Recruiting
North Miami, Florida, United States, 33161
Contact: Claudia Salomon    305-722-8444 ext 2275    csalomon@segaltrials.com   
Principal Investigator: Olga Lapeyra, MD         
Innovative Clinical Research, Inc. Recruiting
North Miami, Florida, United States, 33163
Contact: Claudia Salomon    305-722-8444 ext 2275    csalomon@segaltrials.com   
Principal Investigator: Rishi Kakar, MD         
United States, North Carolina
Segal Trials Recruiting
Charleston, North Carolina, United States, 29407
Contact: Tina Cooper    843-576-6750    tcooper@segaltrials.com   
Principal Investigator: Eduardo Cifuentes, MD         
Sponsors and Collaborators
Akili Interactive Labs, Inc.
Investigators
Principal Investigator: Richard Keefe, PhD Duke Institute for Brain Sciences

Responsible Party: Akili Interactive Labs, Inc.
ClinicalTrials.gov Identifier: NCT03310281     History of Changes
Other Study ID Numbers: Akili-035
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Akili Interactive Labs, Inc.:
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms