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

July 22, 2020 updated by: National Cheng-Kung University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan
        • Recruiting
        • National Cheng Kung University (NCKU) Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2019

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-ER-108-058

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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