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

Phase 4

• Conditions: Schizophrenia; Metabolic Syndrome; Berberine; Metformin
• Interventions: Drug: Metformin; Drug: Berberine

• Registration Number: NCT03708549
• Lead Sponsor: Tianjin Anding Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-13
• Study First Submitted QC: 2018-10-13
• Study First Posted: 2018-10-17
• Study Start: 2021-12-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-16
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin group	Metformin	Metformin 250mg（three times a day） plus Berberine simulant 250mg（three times a day）agent plus any atypical antipsychotic drug Berberine simulant were matched to Berberine in shape, smell and colour were sealed in identical bottles
Berberine group	Berberine	Berberine 300mg（three times a day） plus Metformin simulant 250mg（three times a day）agent plus any atypical antipsychotic drug Metformin simulant were matched to metformin in shape, smell and colour were sealed in identical bottles

Primary Outcome Measures

Name	Time	Method
Changes of Fasting blood samples for Fasting blood glucose(FBG)	0, 4, 8,12 weeks	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
Changes of Triglyceride(TG)	0, 4, 8,12 weeks	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
Changes of High-Density Lipoprotein (HDL)	0, 4, 8,12 weeks	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
Changes of Waist circumference(WC)	0, 4, 8,12 weeks	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
Changes of Blood pressure (BP)，including systolic and diastolic pressure	0, 4, 8,12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Changes of Positive and Negative Syndrome Scale（PANSS）scores	0, 4, 8,12 weeks	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
Changes of Total Cholesterol(TC)	0, 4, 8,12 weeks	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
Changes of C reactive protein	0, 4, 8,12 weeks	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
Changes of Interleukin-1β,Interleukin-6,tumor necrosis factor(TNF-α)	0, 4, 8,12 weeks	Compare Berberine with Metformin on the effect of reducing the levels of Interleukin-1β,Interleukin-6,tumor necrosis factor in schizophrenia patients with metabolic syndrome(MS) after 12 weeks of treatment
Changes of Body mass index(BMI)	0, 4, 8,12 weeks	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

Trial Locations

Locations (1)

Tianjin Anding Hospital; 🇨🇳 Tianjin, Tianjin, China