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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
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate 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 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
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
No intervention




Primary Outcome Measures :
  1. 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.

  2. 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.



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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) will be provided with an Apple watch on which brief cognitive and mood tests will be 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 Patient 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).

Information from the National Library of Medicine

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


Locations
United Kingdom
Takeda Investigative Site
London, United Kingdom
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03067506     History of Changes
Other Study ID Numbers: MDD-5003
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017

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:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms