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

Mood Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04483661
• Other study ID #: B-ER-108-058
• Status: Recruiting
• Start date: November 27, 2019
• Est. completion date: July 31, 2023

Study information

• Verified date: May 2020
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Mood Disorders

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University (NCKU) Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression severity	Clinician rated score by Structure Interview Guide for the Hamilton Depression Rating Scale (17-item)	six months
Secondary	The influence of environmental factor in mood disorder	Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota	six months
Secondary	cognitive function assessed using the Finger Tapping Test (FTT)		six months
Secondary	cognitive function assessed using Wisconsin Card Sorting Test (WCST)		six months
Secondary	cognitive function assessed using Continuous Performance Test (CPT)		six months