Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder

Not Applicable

• Conditions: Bipolar Disorder
• Interventions: Drug: Valproic Acid

• Registration Number: NCT04486092
• Lead Sponsor: National Cheng-Kung University Hospital

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 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

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-10-11
• Status Verified: 2020-01
• Study First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valproic Acid	Valproic Acid	-

Primary Outcome Measures

Name	Time	Method
Gut microbiota composition	12 weeks

Secondary Outcome Measures

Name	Time	Method
Metabolic syndrome	12 weeks

Trial Locations

Locations (1)

National Cheng Kung University (NCKU) Hospital; 🇨🇳 Tainan, Taiwan