Back to resultsComparison of Berberine and Metformin for the Treatment for MS in Schizophrenia Patients
Primary Purpose
Schizophrenia, Metabolic Syndrome, Berberine
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Berberine
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Berberine, Metformin, Metabolic syndrome, Schizophrenia
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.
Sites / Locations
- Tianjin Anding HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Berberine group
Metformin group
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
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
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
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
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
Changes of Interleukin-1β,Interleukin-6,tumor necrosis factor(TNF-α)
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
Full Information
NCT ID
NCT03708549
First Posted
October 13, 2018
Last Updated
February 14, 2022
Sponsor
Tianjin Anding Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03708549
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Anding Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Metabolic Syndrome, Berberine, Metformin
Keywords
Berberine, Metformin, Metabolic syndrome, Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Berberine group
Arm Type
Experimental
Arm Description
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
Arm Title
Metformin group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Berberine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes of Fasting blood samples for Fasting blood glucose(FBG)
Description
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
Time Frame
0, 4, 8,12 weeks
Title
Changes of Triglyceride(TG)
Description
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
Time Frame
0, 4, 8,12 weeks
Title
Changes of High-Density Lipoprotein (HDL)
Description
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
Time Frame
0, 4, 8,12 weeks
Title
Changes of Waist circumference(WC)
Description
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
Time Frame
0, 4, 8,12 weeks
Title
Changes of Blood pressure (BP)，including systolic and diastolic pressure
Description
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
Time Frame
0, 4, 8,12 weeks
Secondary Outcome Measure Information:
Title
Changes of Body mass index(BMI)
Description
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
Time Frame
0, 4, 8,12 weeks
Title
Changes of Positive and Negative Syndrome Scale（PANSS）scores
Description
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
Time Frame
0, 4, 8,12 weeks
Title
Changes of Total Cholesterol(TC)
Description
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
Time Frame
0, 4, 8,12 weeks
Title
Changes of C reactive protein
Description
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
Time Frame
0, 4, 8,12 weeks
Title
Changes of Interleukin-1β,Interleukin-6,tumor necrosis factor(TNF-α)
Description
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
Time Frame
0, 4, 8,12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Li, PHD
Phone
022-88188006
Email
tjlijie3827@163.com
Facility Information:
Facility Name
Tianjin Anding Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Li, Doctor
Phone
+86 022 88188006
Email
tjlijie3827@163.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of Berberine and Metformin for the Treatment for MS in Schizophrenia Patients
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