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

2 de julio de 2018 actualizado por: 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).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

30

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Reino Unido
      • London, Reino Unido
        • Takeda Investigative Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Otro: Sin intervención
Sin intervención

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Days on Which Daily N-back Sessions Were Completed
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Takeda

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de marzo de 2017

Finalización primaria (Actual)

3 de julio de 2017

Finalización del estudio (Actual)

3 de julio de 2017

Fechas de registro del estudio

Enviado por primera vez

26 de febrero de 2017

Primero enviado que cumplió con los criterios de control de calidad

26 de febrero de 2017

Publicado por primera vez (Actual)

1 de marzo de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de enero de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

2 de julio de 2018

Última verificación

1 de julio de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • MDD-5003

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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