Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder

NCT ID: NCT04486092

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Valproic Acid

Group Type EXPERIMENTAL

Valproic Acid

Intervention Type DRUG

Interventions

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Valproic Acid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cheng Kung University (NCKU) Hospital

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hui-Hua Chang, Ph.D.

Role: CONTACT

886-6-2353535 ext. 5683

Facility Contacts

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Hui Hua Chang, PhD

Role: primary

886-2353535 ext. 5683

Other Identifiers

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A-ER-104-031

Identifier Type: -

Identifier Source: org_study_id

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