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

NCT03708549 | Unknown Phase 4

• 1 other identifier: Ber-Met-MS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Metabolic Syndrome; Berberine; Metformin

Keywords

Berberine; Metformin; Metabolic syndrome; Schizophrenia

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Changes of Body mass index(BMI)

  0, 4, 8,12 weeks

• Changes of Positive and Negative Syndrome Scale（PANSS）scores

  0, 4, 8,12 weeks

• Changes of Total Cholesterol(TC)

  0, 4, 8,12 weeks

• Changes of C reactive protein

  0, 4, 8,12 weeks

• Changes of Interleukin-1β,Interleukin-6,tumor necrosis factor(TNF-α)

  0, 4, 8,12 weeks

Study Arms (2)

Berberine group

EXPERIMENTAL

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

Drug: Berberine

Metformin group

ACTIVE COMPARATOR

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

Drug: Metformin

Interventions

Berberine DRUG

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

Berberine group

Metformin DRUG

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

Metformin group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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;
• )Meet metabolic syndrome based on Guidelines for Prevention and Treatment of Blood Lipid Abnormality in Chinese Adults(2007);
• )Have taken stable dose of the current single antipsychotic drug for at least one month;
• \) 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.

You may not qualify if:

• )Individuals who refuse to provide informed consent;
• )Currently substance abuse or psychiatrically unstable per treating clinician's judgment;
• )One with significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases also not suitable for this trial;
• )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.

Sponsors & Collaborators

• Tianjin Anding Hospital: lead

Study Sites (1)

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300222, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Metabolic Syndrome

Interventions

Berberine; Metformin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Jie Li, PHD

CONTACT

022-88188006; tjlijie3827@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2018
• First Posted: October 17, 2018
• Study Start: December 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 16, 2022

Record last verified: 2022-01

Locations

CN (1)