Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder

National Cheng-Kung University

Status

Unknown

Conditions

Bipolar Disorder

Treatments

Drug: Valproic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT04486092

A-ER-104-031

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.