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Recruiting NCT05828056

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

Observational Bipolar Disorder Depressive Disorder

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wearable activity tracker.
Who it may be relevant to
Registry conditions: Bipolar Disorder, Depressive Disorder. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Wearable activity tracker
    Garmin smartwatch will record features, such as activities, heart rate, sleep, through smartphone App

Primary outcome measures

  • Development and verification of mood episode prediction algorithm [Time frame: 1 year]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT05828056 · 202002006RINA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗