Major Depressive DisorderNCT03067506
Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology
An observational study of Major Depressive Disorder, run by Takeda at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2017to 3 Jul 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Has MDD as the primary psychiatric diagnosis.
- Has been treated previously with at least 1 antidepressant (monotherapy).
- Has scores on Participant Health Questionnaire-9 items (PHQ-9) ≥5 and PHQ-9 ≤15 at Screening
Who cannot join
- 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:
- 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).
- Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine).
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- No intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start1 Mar 2017
- Primary completion3 Jul 2017
- Study completion3 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067506
- Sponsor's protocol ID
- MDD-5003
- Status last verified
- Jul 2018
- First submitted
- 26 Feb 2017
- Last updated
- 10 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03067506
- Acronym / sponsor ID
- MDD-5003
- Conditions
- Major Depressive Disorder
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Posted 10 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With Major Depressive Disorder (MDD) | – | Other: No interventionParticipants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Has MDD as the primary psychiatric diagnosis.
- Has been treated previously with at least 1 antidepressant (monotherapy).
- Has scores on Participant Health Questionnaire-9 items (PHQ-9) ≥5 and PHQ-9 ≤15 at Screening
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Participants With Major Depressive Disorder (MDD) |
Primary outcome
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Takeda at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Days on Which Daily N-back Sessions Were Completed (time frame: Baseline up to Week 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.