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Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder | Clinical Trials | Clareo Health

UNKNOWNNA

Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder

NCT04486092•National Cheng-Kung University Hospital

Summary

The potential effects of microbiota in bipolar disorder (BD) with microbiota-related dysfunction have not yet been explored clinically, and the integration of microbiota and pharmacometabolomic approaches can provide us the identification of the significant effects of mood stabilizers on metabolic homeostasis, treatment response, and cognitive performance. Therefore, we propose to develop the integration of the microbiota and pharmacometabolomics knowledge base about the mood stabilizer-induced metabolic abnormalities in BD patients.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Bipolar disorder outpatients (aged 18-65 years) who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria and start to receive valproate (VPA) will be enrolled consecutively by trained psychiatrists.

Exclusion Criteria

•Exclude are patients who had DSM-V diagnosis for substance abuse within the past three months
•Had treated with antibiotics and/or functional foods (probiotics and/or prebiotics) for at least one month before entering study
•Presence of stomach/gut problems such as chronic diarrhea, constipation, gas, heartburn, bloating, etc.
•Had an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness
•Had a surgical condition or a major physical illness
•Were pregnant or breast-feeding
•Had any concomitant DSM-V Axis I diagnoses together with somatic or neurologic illnesses interfering psychiatric evaluation.

Locations (1)

National Cheng Kung University (NCKU) Hospital

Tainan, Taiwan

Key Dates

Start Date

February 1, 2015

Primary Completion Date

July 1, 2021

Completion Date

July 1, 2021

Last Updated

July 24, 2020

Enrollment

200

ESTIMATED participants

Conditions

Bipolar Disorder

Interventions

Valproic Acid

DRUG

Contacts

Hui-Hua Chang, Ph.D.

CONTACT

886-6-2353535 huihua@mail.ncku.edu.tw

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

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