Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology

• ClinicalTrials.gov Identifier: NCT03067506
• Recruitment Status: Completed
• First Posted: March 1, 2017
• Results First Posted: January 10, 2019
• Last Update Posted: January 10, 2019
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

Study Description

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).

Condition or disease	Intervention/treatment
Major Depressive Disorder	Other: No intervention

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures :

1. Percentage of Days on Which Daily N-back Sessions Were Completed [ Time Frame: Baseline up to Week 6 ]
   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.
2. Percentage of Days on Which Daily Mood Assessment Tests Were Completed [ Time Frame: Baseline up to Week 6 ]
   The Daily Mood assessments were completed on the wearable technology (Apple watch) once per day in the afternoon or evening.
3. 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) [ Time Frame: Baseline up to Week 6 ]

   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.

4. Correlation Coefficient Between Measures of Cognition (N-back Scores) and Performance on the CANTAB Test: Rapid Visual Information Processing (RVP) [ Time Frame: Baseline up to Week 6 ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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).

Contacts and Locations

Locations

United Kingdom

Takeda Investigative Site

London, United Kingdom

Sponsors and Collaborators

Takeda

Investigators

• Study Director: Medical Director Clinical Science; Takeda

  Study Documents (Full-Text)

Documents provided by Takeda:

Study Protocol  [PDF] March 10, 2017

Statistical Analysis Plan  [PDF] July 13, 2017

More Information

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT03067506
• Other Study ID Numbers: MDD-5003
• First Posted: March 1, 2017
• Results First Posted: January 10, 2019
• Last Update Posted: January 10, 2019
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:

Drug Therapy

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms