An observational study in Bipolar Disorder and Depressive Disorder, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by National Taiwan University Hospital · Observational
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 100 is below the median of 159 across 348 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Development and verification of mood episode prediction algorithm
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.
Time frame: 1 year
Plan to share: No — 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.
No publications or documents are linked to this record.
Started Mar 2020 (actual). Primary completion is estimated for Dec 2027, 93 months after the start.
Of 95 non-industry observational studies under Bipolar Disorder, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 119. This study's planned 93 months is above that.
Counting every sponsor, half of 105 studies reached it within 64 months; a quarter within 31 and three quarters within 118.
How these figures are worked out, and which studies are left out of them.
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