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Clinical Trials/NCT04483661
NCT04483661
Unknown
Not Applicable

Development of Systems and Precision Medicine - Take Mood Disorder as an Example.

National Cheng-Kung University Hospital1 site in 1 country200 target enrollmentNovember 27, 2019
ConditionsMood Disorders

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mood Disorders
Sponsor
National Cheng-Kung University Hospital
Enrollment
200
Locations
1
Primary Endpoint
Depression severity
Last Updated
5 years ago

Overview

Brief Summary

Precision medicine is to achieve individual optimal health care, given the biological mechanisms, genetic variants, and environmental measurements. Take mood disorder (MD) as an example, we aim to develop systems and precision medicine in Taiwanese population.

MD is a very serious and dysfunctional mental disorder. Since MD patients with treatment have high risk of neurocognitive impairment and metabolic disturbances, the therapeutic strategies are of clinical importance. Individual difference of treatment outcome in MD patients would result from genetic variants, environmental factors, and their interactions. Also, the treatment outcome of MD contains multiple dimensions, including improvement of disease severity, neurocognitive function, and optimized medication strategy. However, comprehensive development of approaches to investigate the multiple dimensions of treatment outcome in MD patients is limited. In this three-year proposal, we explore the interactions of genetic variants and environmental factors (represented by psychosocial stress and gut microbiota) driven approaches to develop precision medicine.

Registry
clinicaltrials.gov
Start Date
November 27, 2019
End Date
July 31, 2023
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or female patients, 20- 70 years of age
  • Major depression disorder who met the DSM-V diagnostic criteria were enrolled
  • Subjects take at least one kind of antidepressant.

Exclusion Criteria

  • Pregnant or breast-feeding
  • Presence of any other major psychiatric illness
  • History of substance and alcohol abuse or dependence
  • Presence of auto-immune disorder and infectious diseases

Outcomes

Primary Outcomes

Depression severity

Time Frame: six months

Clinician rated score by Structure Interview Guide for the Hamilton Depression Rating Scale (17-item)

Secondary Outcomes

  • cognitive function assessed using Wisconsin Card Sorting Test (WCST)(six months)
  • cognitive function assessed using the Finger Tapping Test (FTT)(six months)
  • The influence of environmental factor in mood disorder(six months)
  • cognitive function assessed using Continuous Performance Test (CPT)(six months)

Study Sites (1)

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