Software Treatments for Actively Reducing Severity of Cognitive Deficits in MDD (STARS-MDD)
NCT03310281, Not applicable, Completed, Akili Interactive Labs, Inc.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Software Treatments for Actively Reducing Severity of Cognitive Deficits in MDD (STARS-MDD) | ClinicalTrials.gov |
| NCT number | NCT03310281 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 84 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Akili Interactive Labs, Inc. | ClinicalTrials.gov |
| Conditions | Major Depressive Disorder | ClinicalTrials.gov |
| Interventions | HOLD: Videogame | ClinicalTrials.gov |
| First posted | 2017-10-16 | ClinicalTrials.gov |
| Last updated | 2018-11-21 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in reaction time to rare target stimuli, from the Test of Variables of Attention (TOVA) | 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. | ClinicalTrials.gov |
| Secondary | 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 | 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 | ClinicalTrials.gov |
| Secondary | Change in Patient Deficit Questionnaire (PDQ) score | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Secondary | Change in Letter Number Span (LNS) working memory test score | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Secondary | Change in Stroop color and words test score | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Secondary | Change in Trail-making tests A and B scores | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Secondary | Change in BAC Symbol Coding Test score | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Secondary | Change in Trait Adjective Task score | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Other | Exploratory Outcome Measure: Change in Hamilton Depression Scale HAM-D_17 (6 depression-focused subset) | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Other | Exploratory Outcome Measure: Change in Patient Health Questionnaire 9 (PHQ-9) score | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Other | 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 | ClinicalTrials.gov | |
| Other | Exploratory Outcome Measure: Change in Cognitive and Physical Functioning Questionnaire (CPFQ) total scores | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Other | Exploratory Outcome Measure: Change in Patient Deficit Questionnaire (PDQ) score | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Other | Exploratory Outcome Measure: Change in Test of Variable of Attention (TOVA) Attention Performance Index (API) | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Other | Exploratory Outcome Measure: Change in Quality of Life, Enjoyment and satisfaction Questionnaire - Global Function (Q-LES-Q) scores | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Other | Exploratory Outcome Measure: Change in Work & Social Adjustment Scale (WSAS) score | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Other | Exploratory Outcome Measure: Change in Emotional Regulation Questionnaire (ERQ) score | Study Day 0 to Study Day 42 | ClinicalTrials.gov | |
| Other | Exploratory Outcome Measure: Change in Difficulty in Emotional Regulation Scale (DERS) score | Study Day 0 to Study Day 42 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)