Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder

Bipolar Disorder Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04486092
• Other study ID #: A-ER-104-031
• Status: Recruiting
• Phase: N/A
• Start date: February 2015
• Est. completion date: July 2021

Study information

• Verified date: January 2020
• Source: National Cheng-Kung University Hospital
• Contact: Hui-Hua Chang, Ph.D.
• Phone: 886-6-2353535
• Email: huihua[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Valproic Acid

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University (NCKU) Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota composition		12 weeks
Secondary	Metabolic syndrome		12 weeks