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

NCT04483661 | Unknown

• 1 other identifier: B-ER-108-058
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Depression severity

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

  six months

Secondary Outcomes (4)

• The influence of environmental factor in mood disorder

  six months

• 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

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who met the criteria will be successively recruited from the National Cheng Kung University Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University (NCKU) Hospital

Tainan, Taiwan

RECRUITING

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 23, 2020
• Study Start: November 27, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 23, 2020

Record last verified: 2020-05

Locations

TW (1)