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

• Conditions: Mood Disorders

• Registration Number: NCT04483661
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-27
• Status Verified: 2020-05
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-22
• Last Update Submitted: 2020-07-22
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression severity	six months	Clinician rated score by Structure Interview Guide for the Hamilton Depression Rating Scale (17-item)

Secondary Outcome Measures

Name	Time	Method
cognitive function assessed using the Finger Tapping Test (FTT)	six months
cognitive function assessed using Wisconsin Card Sorting Test (WCST)	six months
cognitive function assessed using Continuous Performance Test (CPT)	six months
The influence of environmental factor in mood disorder	six months	Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota

Trial Locations

Locations (1)

National Cheng Kung University (NCKU) Hospital; 🇨🇳 Tainan, Taiwan