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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With Major Depressive Disorder (MDD) | Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Days on Which Daily N-back Sessions Were Completed | The cognitive assessment n-back test was completed on the wearable technology (Apple watch) on 3 occasions across the day in the morning, afternoon and evening. | Baseline up to Week 6 |
| Percentage of Days on Which Daily Mood Assessment Tests Were Completed | The Daily Mood assessments were completed on the wearable technology (Apple watch) once per day in the afternoon or evening. | Baseline up to Week 6 |
| 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) | The n-back was used to assess cognition 3 times a day. Participants responded by touching the watch face when a symbol matched the one presented 2-back. Average daily n-back score (d-prime) was calculated. CANTAB tests consists of a battery of neuropsychological tests. Spatial Working Memory (SWM) assessed retention of spatial data, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. SWMBE=cumulative number of times participant went back to box that a token was previously removed per each successful study. Lower score was better. SWMS=number of unique boxes participant searched in two 6 and 8 box trials. Total of 4 trial scores ranged from 4-28. Lower score indicated better performance. Pearson's correlation coefficient measured linear correlation between n-back scores from Apple Watch and CANTAB tests, provided as a value +1=positive correlation to -1=negative correlation. 0=no correlation. | Baseline up to Week 6 |
| Correlation Coefficient Between Measures of Cognition (N-back Scores) and Performance on the CANTAB Test: Rapid Visual Information Processing (RVP) | The n-back was used to assess cognition 3 times a day. Participants responded by touching the watch face when a symbol matched the one presented 2-back. Average daily n-back score (d-prime) was calculated. CANTAB tests consists of a battery of neuropsychological tests. RVP measures sustained attention. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits. RVPA=measure of sensitivity to the target, regardless of response tendency (expected range is 0.00 to 1.00). Speed of Processing (RVPMDL)=The mean response latency during assessment sequence blocks where the participant responded correctly. Pearson's correlation coefficient measured linear correlation between n-back scores from Apple Watch and CANTAB tests, provided a value +1=positive correlation to -1=negative correlation. 0=no correlation. |
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Inclusion Criteria:
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Investigative Site | London | United Kingdom |
Participants with a diagnosis of major depressive disorder (MDD) prescribed first-, second- or third-line antidepressant monotherapy were provided with an Apple watch on which brief cognitive and mood tests were evaluated.
Participants took part in the study at 1 investigative site in the United Kingdom from 29 February 2017 to 03 July 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Major Depressive Disorder (MDD) | Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Major Depressive Disorder (MDD) | Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Days on Which Daily N-back Sessions Were Completed | The cognitive assessment n-back test was completed on the wearable technology (Apple watch) on 3 occasions across the day in the morning, afternoon and evening. | Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study. | Posted | Mean | Standard Deviation | percentage of days | Baseline up to Week 6 |
|
|
Baseline up to Week 6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Major Depressive Disorder (MDD) | Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2017 | Jul 2, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2017 | Jul 2, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Baseline up to Week 6 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Screening Patient Health Questionnaire-9 items (PHQ 9) | PHQ-9 is a 9-items scale to assess depression. Each item is rated (0=not at all to 3=nearly every day) for total score 0-27 (higher scores indicate severe depression). | Mean | Standard Deviation | score on a scale |
|
| Comorbid Anxiety | Number | participants |
|
| Current Medication | Number | participants |
|
| Current Medication by Category | Number | participants |
|
| Time on Current Medication | Mean | Standard Deviation | months |
|
| Medical Switch | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Percentage of Days on Which Daily Mood Assessment Tests Were Completed | The Daily Mood assessments were completed on the wearable technology (Apple watch) once per day in the afternoon or evening. | Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study. | Posted | Mean | Standard Deviation | percentage of days | Baseline up to Week 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) | The n-back was used to assess cognition 3 times a day. Participants responded by touching the watch face when a symbol matched the one presented 2-back. Average daily n-back score (d-prime) was calculated. CANTAB tests consists of a battery of neuropsychological tests. Spatial Working Memory (SWM) assessed retention of spatial data, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. SWMBE=cumulative number of times participant went back to box that a token was previously removed per each successful study. Lower score was better. SWMS=number of unique boxes participant searched in two 6 and 8 box trials. Total of 4 trial scores ranged from 4-28. Lower score indicated better performance. Pearson's correlation coefficient measured linear correlation between n-back scores from Apple Watch and CANTAB tests, provided as a value +1=positive correlation to -1=negative correlation. 0=no correlation. | Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study. | Posted | Number | 95% Confidence Interval | Correlation Coefficient (r) | Baseline up to Week 6 |
|
|
|
| Primary | Correlation Coefficient Between Measures of Cognition (N-back Scores) and Performance on the CANTAB Test: Rapid Visual Information Processing (RVP) | The n-back was used to assess cognition 3 times a day. Participants responded by touching the watch face when a symbol matched the one presented 2-back. Average daily n-back score (d-prime) was calculated. CANTAB tests consists of a battery of neuropsychological tests. RVP measures sustained attention. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits. RVPA=measure of sensitivity to the target, regardless of response tendency (expected range is 0.00 to 1.00). Speed of Processing (RVPMDL)=The mean response latency during assessment sequence blocks where the participant responded correctly. Pearson's correlation coefficient measured linear correlation between n-back scores from Apple Watch and CANTAB tests, provided a value +1=positive correlation to -1=negative correlation. 0=no correlation. | Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study. | Posted | Number | 95% Confidence Interval | Correlation Coefficient (r) | Baseline up to Week 6 |
|
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.