Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology
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|ClinicalTrials.gov Identifier: NCT03067506|
Recruitment Status : Completed
First Posted : March 1, 2017
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment|
|Major Depressive Disorder||Other: No intervention|
The novel method being tested in this study for assessing mood and cognition in participants with MDD is wearable technology. This study will look 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 will enroll approximately 30 patients. Participants will be provided with a watch on which brief cognitive and mood tests will be evaluated daily up to 6 weeks.
All participants will be prompted to complete cognitive and mood assessments on 3 occasions across the day. Two occasions (morning and afternoon) will comprise assessment of cognition, and the final assessment in the evening will constitute a review of the day focusing on self-reported depressed mood.
This single-center trial will be conducted in United Kingdom. The overall time to participate in this study is 6 weeks. Participants will take part in 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.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|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|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||July 3, 2017|
|Actual Study Completion Date :||July 3, 2017|
Participants With Major Depressive Disorder (MDD)
Participants with MDD will be provided with an Apple watch on which brief cognitive and mood tests will be evaluated daily up to 6 weeks.
Other: No intervention
- Number of Wearable Tests Completed Over the 6-week Study Period [ Time Frame: Baseline up to Week 6 ]Wearable tests include cognitive assessment and mood assessment done on the wearable technology. Participants will be prompted to complete cognitive and mood assessments on 3 occasions across the day.
- Correlations Between Measures of Cognition on the Wearable Technology (n-Back d') and Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) Tests [ Time Frame: Baseline up to Week 6 ]The n-back measures cognition where n=1 or 2. In 2-back test, participants respond when symbol is same as presented 2 earlier. In 2-back, latency and d' measure accuracy=ratio hits (correct detection) and false alarms. A +ve change from baseline=improvement. CANTAB test consists of battery of neuropsychological tests, involving distinct cognitive domains: 1) emotion recognition task to measure accuracy of answers. Higher scores is better.2) Spatial working memory assesses retention of spatial data, ability to manipulate remembered items and strategize. The participant is asked to find tokens in on-screen boxes and move them. Difficulty ranges=4-8 box assessments, 2 trials for each assessment. Range=0-175. Lower scores is better.3) Rapid Visual Information Processing measures sustained attention. Digits from 2-9 appear in pseudo-random order, at rate of 100 digits/minute in a white box on screen. Participants detect order of digits and register (range=0.0-1.0). Higher scores is better.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067506
|Takeda Investigative Site|
|London, United Kingdom|
|Study Director:||Medical Director Clinical Science||Takeda|