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

July 2, 2018 updated by: Takeda

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline up to Week 6
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.
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)
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.
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)
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.
Baseline up to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDD-5003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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