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

May 4, 2023 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2020

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Estimate)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202002006RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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