Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 11, 2015
CompletedFirst Posted
Study publicly available on registry
July 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedJuly 24, 2020
January 1, 2020
6.4 years
October 11, 2015
July 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Gut microbiota composition
12 weeks
Secondary Outcomes (1)
Metabolic syndrome
12 weeks
Study Arms (1)
Valproic Acid
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng Kung University (NCKU) Hospital
Tainan, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2015
First Posted
July 24, 2020
Study Start
February 1, 2015
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
July 24, 2020
Record last verified: 2020-01