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Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Valproic Acid
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • National Cheng Kung University (NCKU) HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valproic Acid

Arm Description

Outcomes

Primary Outcome Measures

Gut microbiota composition

Secondary Outcome Measures

Metabolic syndrome

Full Information

First Posted
October 11, 2015
Last Updated
July 21, 2020
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04486092
Brief Title
Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Valproic Acid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Valproic Acid
Primary Outcome Measure Information:
Title
Gut microbiota composition
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Metabolic syndrome
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Hua Chang, Ph.D.
Phone
886-6-2353535
Ext
5683
Email
huihua@mail.ncku.edu.tw
Facility Information:
Facility Name
National Cheng Kung University (NCKU) Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Hua Chang, PhD
Phone
886-2353535
Ext
5683
Email
huihua@mail.ncku.edu.tw

12. IPD Sharing Statement

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Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder

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