N/A
N=30
Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03067506 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Percentage of Days on Which Daily N-back Sessions Were Completed — 95.63 percentage of days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Days on Which Daily N-back Sessions Were Completed |
95.63 | — |
| PRIMARY Percentage of Days on Which Daily Mood Assessment Tests Were Completed |
94.6 | — |
| PRIMARY Correlation Coefficient Between Measures of Cognition (N-back Scores) and Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) Tests: Spatial Working Memory Between Errors (SWMBE) and Spatial Working Memory Strategy (SWMS) |
-0.46; -0.37 | — |
| PRIMARY Correlation Coefficient Between Measures of Cognition (N-back Scores) and Performance on the CANTAB Test: Rapid Visual Information Processing (RVP) |
0.50; -0.40 | — |
Summary
The purpose of this study was to evaluate the feasibility and compliance with a novel method for assessing mood and cognition in participants with major depressive disorder (MDD).
Eligibility Criteria
Inclusion Criteria
- Has MDD as the primary psychiatric diagnosis.
- Has been treated previously with at least 1 antidepressant (monotherapy).
- Has scores on Participant Health Questionnaire-9 items (PHQ-9) ≥5 and PHQ-9 ≤15 at Screening
Exclusion Criteria
- Has a significant risk of suicide according to the investigator's clinical judgment or has made an actual suicide attempt in the previous 6 months prior to Screening.
- Has a history of only responding to either combination or augmentation therapy in the current episode and has had been treated for more than a year without any period of remission.
- Has 1 or more of the following:
- Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
- Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine).
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Data sourced from ClinicalTrials.gov (NCT03067506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.