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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04483661

Enrollment

200

Registered

2020-07-23

Start date

2019-11-27

Completion date

2023-07-31

Last updated

2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mood Disorders

Keywords

mood disorder, neurocognitive function, metabolic disturbances, microbiota-gut-brain axis, genetic variant, pharmacogenomics

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
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	—

Countries

Taiwan

Outcome results