Comparison of Berberine and Metformin for the Treatment for MS in Schizophrenia Patients

Schizophrenia Clinical Trial

Official title:

Comparison of the Efficacy and Safety of Berberine and Metformin for Schizophrenia Patients With Metabolic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03708549
• Other study ID #: Ber-Met-MS
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2022
• Source: Tianjin Anding Hospital
• Contact: Jie Li, PHD
• Phone: 022-88188006
• Email: tjlijie3827[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Berberine
• Metabolic Syndrome
• Metformin
• Schizophrenia
• Syndrome

Intervention

Drug:
• Berberine
The patients will randomly assigned to receive berberine (900 mg day-1, three times a day) and metformin simulant(750mg day-1, three times a day) on the basis of the second-generation antipsychotics monotherapy
• Metformin
The patients will randomly assigned to receive metformin (750 mg day-1, three times a day) and berberine simulant(900mg day-1, three times a day) on the basis of the second-generation antipsychotics monotherapy

Locations

Country	Name	City	State
China	Tianjin Anding Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Anding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Fasting blood samples for Fasting blood glucose(FBG)	The main objective is to compare Berberine with Metformin on the effect of reducing the levels of FBG in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment	0, 4, 8,12 weeks
Primary	Changes of Triglyceride(TG)	The main objective is to compare Berberine with Metformin on the effect of reducing the levels of TG in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment	0, 4, 8,12 weeks
Primary	Changes of High-Density Lipoprotein (HDL)	The main objective is to compare Berberine with Metformin on the effect of reducing the levels of HDL in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment	0, 4, 8,12 weeks
Primary	Changes of Waist circumference(WC)	The main objective is to compare Berberine with Metformin on the effect of reducing the levels of WC in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment	0, 4, 8,12 weeks
Primary	Changes of Blood pressure (BP),including systolic and diastolic pressure	The main objective is to compare Berberine with Metformin on the effect of reducing the levels of systolic or diastolic pressure in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment	0, 4, 8,12 weeks
Secondary	Changes of Body mass index(BMI)	Compare Berberine with Metformin on the effect of reducing the levels of BP in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment	0, 4, 8,12 weeks
Secondary	Changes of Positive and Negative Syndrome Scale(PANSS)scores	Positive and Negative Syndrome Scale(PANSS)has been used to assess symptom severity in schizophrenia.Of the items included in PANSS ,seven constitute a Positive scale,seven form a Negative scale and sixteen constitute a General Psychopathology scale.7-point rating instrument was conceived.A total Score is computed three subscales.Minimum scores is 30 and maximum scores is 210.The higher score are considered the psychiatric symptoms more serious.Compare Berberine with Metformin on the effect of reducing the levels of the scores of PANSS in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment	0, 4, 8,12 weeks
Secondary	Changes of Total Cholesterol(TC)	Compare Berberine with Metformin on the effect of reducing the levels of TC in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment	0, 4, 8,12 weeks
Secondary	Changes of C reactive protein	Compare Berberine with Metformin on the effect of reducing the levels of C reactive protein in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment	0, 4, 8,12 weeks
Secondary	Changes of Interleukin-1ß,Interleukin-6,tumor necrosis factor(TNF-a)	Compare Berberine with Metformin on the effect of reducing the levels of Interleukin-1ß,Interleukin-6,tumor necrosis factor in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment	0, 4, 8,12 weeks