Status:
COMPLETED
A 12-weeks Study to Evaluate the Dietary Fiber and Probiotics Treatment in Prevention and Intervention of Weight-gain and Cognitive Impairment of Schizophrenia or Bipolar Disorder
Lead Sponsor:
Central South University
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
In this study, the investigators will evaluate the efficacy, safety and related mechanism of dietary fiber and probiotics alone and in combination as a add-on treatment in improving the antipsychotic ...
Detailed Description
In this study, the investigators will evaluate the efficacy, safety and related mechanism of dietary fiber and probiotics alone and in combination as a add-on treatment in improving the antipsychotic ...
Eligibility Criteria
Inclusion
- Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia or bipolar disorder;
- Patients with a weight gain of more than 10% after taking antipsychotic medications;
- Male and female with aged 18 to 65 years;
- PANSS total score \< 60 or HAMD-17 total score≤ 7 and YMRS total score\<5;
- Signed the study consent for participation;
- Not allergy to probiotics or dietary fiber medicine
- On stable medication and dosage for at least 3 months.
Exclusion
- Having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;
- Having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
- Taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;
- Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
- The routine blood tests showing abnormal renal, liver function;
- Pregnant or lactating women.
- No administration of any antibiotics in two mouths
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT03379597
Start Date
November 30 2017
End Date
June 30 2021
Last Update
April 19 2023
Active Locations (1)
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1
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011