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

NCT03067506 | Completed Results

• 1 other identifier: MDD-5003
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Disorder

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline up to Week 6

Study Arms (1)

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

Interventions

No intervention OTHER

No intervention

Participants With Major Depressive Disorder (MDD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda Investigative Site

London, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2017
• First Posted: March 1, 2017
• Study Start: March 1, 2017
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: January 10, 2019
• Results First Posted: January 10, 2019

Record last verified: 2018-07

Locations

GB (1)