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Prediction on the Recurrence of Manic and Depressive Episodes in Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT05828056
Recruitment Status : Recruiting
First Posted : April 25, 2023
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
Mood disorders (including bipolar disorder and major depressive disorder) are chronic mental disorders with high recurrent rate. The more the number of recurrence is, the worse long-term prognosis is. This study aims to establish a prediction model of recurrence of manic and depressive episodes in mood disorders, with a hope to detect recurrence relapse as early as possible for timely clinical intervention. We will adopt wearable smart watch to collect heart rate, sleep pattern, activity level, as well as emotional status for one year long in 100 patients with bipolar disorder, and annotated their mood status (i.e., manic episode, depressive episode, and euthymic state). We expect to establish prediction models to predict the recurrence of mood episodes.

Condition or disease Intervention/treatment
Bipolar Disorder Depressive Disorder Device: Wearable activity tracker

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prediction on the Recurrence of Manic and Depressive Episodes in Bipolar Disorder
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Groups and Cohorts
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Group/Cohort Intervention/treatment
BP
100 patients with mood disorders from the psychiatric ward and outpatient services of the Department of Psychiatry, National Taiwan University Hospital
 Device: Wearable activity tracker
Garmin smartwatch will record features, such as activities, heart rate, sleep, through smartphone App


Outcome Measures
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Primary Outcome Measures :
  1. Development and verification of mood episode prediction algorithm [ Time Frame: 1 year ]
    Collected data will apply to learning algorithm, random forest, which constructs a multitude of decision trees at training time and outputting a class that is the mode of the classes of the individual trees. Performance of the trained prediction model was evaluated by assessing the model's accuracy, sensitivity, specificity, and the area under the curve. In a machine learning evaluation process, a part of data is used for model training, and the other portion is used for model testing.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will recruit 100 patients with mood disorders from the psychiatric ward and outpatient services of the Department of Psychiatry, National Taiwan University Hospital. All the participants will be followed for one year to collect the daily activity level, sleep patterns, heart rate through actigraphy, as well as location, mood report, drug compliance and face photo through smartphone app that will be developed by Co-PI Lai.
Criteria

Inclusion Criteria:

  • DSM-5 Bipolar disorder or depressive disorder
  • 20~60 years old
  • Willing to carry smartwatch and smartphone most of the time

Exclusion Criteria:

  • Comorbid with substance use disorder
  • Unable to use smartwatch and smartphone
Contacts and Locations
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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): NCT05828056


Contacts
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Contact: Yi-Ling Chien +886223123456#66013 chienyiling@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Yi-Ling Chien, MD, PhD    +886223123456#66013    chienyiling@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT05828056    
Other Study ID Numbers: 202002006RINA
First Posted: April 25, 2023    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All the data in this study will be appropriately maintained with protection of privacy and confidentiality. Any personal identifiable data will be replaced by research ID number.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
biomarker
Bipolar disorder
Additional relevant MeSH terms:
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Recurrence
Depressive Disorder
Bipolar Disorder
Mood Disorders
 Mental Disorders
Disease Attributes
Pathologic Processes
Bipolar and Related Disorders