Clinical trial NCT03067506: Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology
Official title: A Single Center Pilot Study to Evaluate Real Time Passive and Active High-Frequency Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with major depressive disorder (MDD) were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.

Brief 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).

Detailed description: The novel method being tested in this study for assessing mood and cognition in participants with MDD was wearable technology. This study looked at the correlation of mood and cognition outcomes on wearable technology with traditional objective neuropsychological cognitive function tests and self-reported mood outcomes.

The study enrolled approximately 30 patients. Participants were provided with a watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.

All participants prompted to complete cognitive and mood assessments on 3 occasions across the day. Two occasions (morning and afternoon) comprised assessment of cognition, and the final assessment in the evening constituted a review of the day focusing on self-reported depressed mood.

This single-center trial was conducted in United Kingdom. The overall time to participate in this study was 6 weeks. Participants took part up to 5 study visits (1 in-person on-site visit, 3 web-based and 1 at home visit) assessing performance on traditional objective neuropsychological cognitive function tests and self-reported measures of depression symptom severity and social function.

Eligibility criteria: Inclusion Criteria:

1. Has MDD as the primary psychiatric diagnosis.
2. Has been treated previously with at least 1 antidepressant (monotherapy).
3. Has scores on Participant Health Questionnaire-9 items (PHQ-9) ≥5 and PHQ-9 ≤15 at Screening

Exclusion Criteria:

1. 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.
2. 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.
3. Has 1 or more of the following:

   1. 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).
   2. Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine).
   3. Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).

Primary outcomes:
measure: Percentage of Days on Which Daily N-back Sessions Were Completed
timeFrame: Baseline up to Week 6
measure: Percentage of Days on Which Daily Mood Assessment Tests Were Completed
timeFrame: Baseline up to Week 6
measure: 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)
timeFrame: Baseline up to Week 6
measure: Correlation Coefficient Between Measures of Cognition (N-back Scores) and Performance on the CANTAB Test: Rapid Visual Information Processing (RVP)
timeFrame: Baseline up to Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Takeda Investigative Site
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: