Clinical trial NCT03708549: Comparison of Berberine and Metformin for the Treatment for MS in Schizophrenia Patients
Official title: Comparison of the Efficacy and Safety of Berberine and Metformin for Schizophrenia Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Metabolic Syndrome
Berberine
Metformin
Keywords: Berberine
Metformin
Metabolic syndrome
Schizophrenia
Lead sponsor: Tianjin Anding Hospital
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Berberine is an isoquinoline alkaloid extracted from medicinal herbs, has been demonstrated to produce beneficial effects on diabetes and hyperlipidemia, fewer study reported its modification on lipid metabolism in schizophrenia. Metformin, have been used for metabolic abnormalities in schizophrenia, findings from these studies indicated that they did have some effect,which are still in experimental stage.This study is aim to compare the efficacy and safety of berberine and metformin for preventing metabolic dysfunction in schizophrenia patients.


Eligibility criteria: Inclusion Criteria:

* 1) In accordance with criteria set out in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV )Axis I Disorders, Clinical Version;
* 2)Meet metabolic syndrome based on Guidelines for Prevention and Treatment of Blood Lipid Abnormality in Chinese Adults(2007);
* 3)Have taken stable dose of the current single antipsychotic drug for at least one month;
* 4) Female subjects will be enrolled to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.

Exclusion Criteria:

* 1)Individuals who refuse to provide informed consent;
* 2)Currently substance abuse or psychiatrically unstable per treating clinician's judgment;
* 3)One with significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases also not suitable for this trial;
* 4)Currently on anti-inflammatory or immunosuppressant medication including oral steroids and history of chronic infection (including tuberculosis, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition pregnancy or breastfeeding.

Primary outcomes:
measure: Changes of Fasting blood samples for Fasting blood glucose(FBG)
timeFrame: 0, 4, 8,12 weeks
measure: Changes of Triglyceride(TG)
timeFrame: 0, 4, 8,12 weeks
measure: Changes of High-Density Lipoprotein (HDL)
timeFrame: 0, 4, 8,12 weeks
measure: Changes of Waist circumference(WC)
timeFrame: 0, 4, 8,12 weeks
measure: Changes of Blood pressure (BP)，including systolic and diastolic pressure
timeFrame: 0, 4, 8,12 weeks
Secondary outcomes:
measure: Changes of Body mass index(BMI)
timeFrame: 0, 4, 8,12 weeks
measure: Changes of Positive and Negative Syndrome Scale（PANSS）scores
timeFrame: 0, 4, 8,12 weeks
measure: Changes of Total Cholesterol(TC)
timeFrame: 0, 4, 8,12 weeks
measure: Changes of C reactive protein
timeFrame: 0, 4, 8,12 weeks
measure: Changes of Interleukin-1β,Interleukin-6,tumor necrosis factor(TNF-α)
timeFrame: 0, 4, 8,12 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Tianjin
Study officials:
References: