Status:
UNKNOWN
Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 approa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04486092
Start Date
February 1 2015
End Date
July 1 2021
Last Update
July 24 2020
Active Locations (1)
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1
National Cheng Kung University (NCKU) Hospital
Tainan, Taiwan