Major Depressive DisorderNCT03310281
Software Treatments for Actively Reducing Severity of Cognitive Deficits in MDD (STARS-MDD)
A study testing HOLD: Videogame in people with Major Depressive Disorder, run by Akili Interactive Labs, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- HOLD: Videogame
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Dec 2017to 14 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Segal Trials
Charleston, North Carolina, 29407
CNS Network, Inc.
Garden Grove, California, 92845
Behavioral Clinical Research, Inc.
North Miami, Florida, 33161
Innovative Clinical Research, Inc.
North Miami, Florida, 33163
About this study
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
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- HOLD: Videogame
- Keywords
- Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOLD: VideogameDevice
Videogame-like digital therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: HOLD: Videogame |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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
Measured: Study Day 0 to Study Day 42
Change in Patient Deficit Questionnaire (PDQ) score
Measured: Study Day 0 to Study Day 42
Change in Letter Number Span (LNS) working memory test score
Measured: Study Day 0 to Study Day 42
Change in Stroop color and words test score
Measured: Study Day 0 to Study Day 42
Change in Trail-making tests A and B scores
Measured: Study Day 0 to Study Day 42
Change in BAC Symbol Coding Test score
Measured: Study Day 0 to Study Day 42
Change in Trait Adjective Task score
Measured: Study Day 0 to Study Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start4 Dec 2017
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akili Interactive Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Keefe, PhD, Principal investigator, Duke Institute for Brain Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310281
- Sponsor's protocol ID
- Akili-035
- Status last verified
- Nov 2018
- First submitted
- 11 Oct 2017
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03310281
- Acronym / sponsor ID
- Akili-035
- Conditions
- Major Depressive Disorder
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Akili Interactive Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALK-T03 | Active comparator | Device: HOLD: VideogameAKL-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. |
| AKL-T09 | Active comparator | Device: HOLD: VideogameAKL-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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOLD: VideogameVideogame-like digital therapy | Device | AKL-T09, ALK-T03 |
Primary outcome
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.
7 secondary outcomes
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
Change in Patient Deficit Questionnaire (PDQ) score
Time frame: Study Day 0 to Study Day 42
Change in Letter Number Span (LNS) working memory test score
Time frame: Study Day 0 to Study Day 42
Change in Stroop color and words test score
Time frame: Study Day 0 to Study Day 42
Change in Trail-making tests A and B scores
Time frame: Study Day 0 to Study Day 42
Change in BAC Symbol Coding Test score
Time frame: Study Day 0 to Study Day 42
Change in Trait Adjective Task score
Time frame: Study Day 0 to Study Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Keefe, PhD principal investigator
Duke Institute for Brain Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOLD: Videogame in people with Major Depressive Disorder, run by Akili Interactive Labs, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.