Trial Outcomes & Findings for Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology (NCT NCT03067506)
NCT ID: NCT03067506
Last Updated: 2019-01-10
Results Overview
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.
COMPLETED
30 participants
Baseline up to Week 6
2019-01-10
Participant Flow
Participants took part in the study at 1 investigative site in the United Kingdom from 29 February 2017 to 03 July 2017.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants With Major Depressive Disorder (MDD)
n=30 Participants
Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.
|
|---|---|
|
Age, Continuous
|
37.23 years
STANDARD_DEVIATION 10.41 • n=30 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=30 Participants
|
|
Region of Enrollment
United Kingdom
|
30 Participants
n=30 Participants
|
|
Screening Patient Health Questionnaire-9 items (PHQ 9)
|
9.13 score on a scale
STANDARD_DEVIATION 3.13 • n=30 Participants
|
|
Comorbid Anxiety
|
20 participants
n=30 Participants
|
|
Current Medication
Amitriptyline
|
4 participants
n=30 Participants
|
|
Current Medication
Citalopram
|
9 participants
n=30 Participants
|
|
Current Medication
Escitalopram
|
1 participants
n=30 Participants
|
|
Current Medication
Fluoxetine
|
2 participants
n=30 Participants
|
|
Current Medication
Mirtazapine
|
2 participants
n=30 Participants
|
|
Current Medication
Sertraline
|
8 participants
n=30 Participants
|
|
Current Medication
Trazodone
|
1 participants
n=30 Participants
|
|
Current Medication
Venlafaxine
|
3 participants
n=30 Participants
|
|
Current Medication by Category
Serotonin Antagonist and Reuptake Inhibitor (SARI)
|
1 participants
n=30 Participants
|
|
Current Medication by Category
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
|
5 participants
n=30 Participants
|
|
Current Medication by Category
Selective Serotonin Reuptake Inhibitor (SSRI)
|
20 participants
n=30 Participants
|
|
Current Medication by Category
Tricyclic Antidepressant (TCA)
|
4 participants
n=30 Participants
|
|
Time on Current Medication
|
9.93 months
STANDARD_DEVIATION 9.74 • n=30 Participants
|
|
Medical Switch
|
24 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study.
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.
Outcome measures
| Measure |
Participants With Major Depressive Disorder (MDD)
n=30 Participants
Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.
|
|---|---|
|
Percentage of Days on Which Daily N-back Sessions Were Completed
|
95.63 percentage of days
Standard Deviation 9.28
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study.
The Daily Mood assessments were completed on the wearable technology (Apple watch) once per day in the afternoon or evening.
Outcome measures
| Measure |
Participants With Major Depressive Disorder (MDD)
n=30 Participants
Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.
|
|---|---|
|
Percentage of Days on Which Daily Mood Assessment Tests Were Completed
|
94.6 percentage of days
Standard Deviation 9.73
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study.
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.
Outcome measures
| Measure |
Participants With Major Depressive Disorder (MDD)
n=30 Participants
Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.
|
|---|---|
|
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)
SWMBE
|
-0.46 Correlation Coefficient (r)
Interval -0.7 to -0.11
|
|
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)
SWMS
|
-0.37 Correlation Coefficient (r)
Interval -0.65 to -0.01
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study.
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.
Outcome measures
| Measure |
Participants With Major Depressive Disorder (MDD)
n=30 Participants
Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.
|
|---|---|
|
Correlation Coefficient Between Measures of Cognition (N-back Scores) and Performance on the CANTAB Test: Rapid Visual Information Processing (RVP)
RVPA (Sensitivity to Target)
|
0.50 Correlation Coefficient (r)
Interval 0.17 to 0.73
|
|
Correlation Coefficient Between Measures of Cognition (N-back Scores) and Performance on the CANTAB Test: Rapid Visual Information Processing (RVP)
RVPMDL (Speed of Processing)
|
-0.40 Correlation Coefficient (r)
Interval -0.67 to -0.04
|
Adverse Events
Participants With Major Depressive Disorder (MDD)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER