- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03708549
Comparison of Berberine and Metformin for the Treatment for MS in Schizophrenia Patients
Comparison of the Efficacy and Safety of Berberine and Metformin for Schizophrenia Patients With Metabolic Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jie Li, PHD
- Phone Number: 022-88188006
- Email: tjlijie3827@163.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300222
- Recruiting
- Tianjin Anding Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Berberine group
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 |
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
|
Active Comparator: Metformin group
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 |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of Fasting blood samples for Fasting blood glucose(FBG)
Time Frame: 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
|
0, 4, 8,12 weeks
|
Changes of Triglyceride(TG)
Time Frame: 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
|
0, 4, 8,12 weeks
|
Changes of High-Density Lipoprotein (HDL)
Time Frame: 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
|
0, 4, 8,12 weeks
|
Changes of Waist circumference(WC)
Time Frame: 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
|
0, 4, 8,12 weeks
|
Changes of Blood pressure (BP),including systolic and diastolic pressure
Time Frame: 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
|
0, 4, 8,12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of Body mass index(BMI)
Time Frame: 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
|
0, 4, 8,12 weeks
|
Changes of Positive and Negative Syndrome Scale(PANSS)scores
Time Frame: 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
|
0, 4, 8,12 weeks
|
Changes of Total Cholesterol(TC)
Time Frame: 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
|
0, 4, 8,12 weeks
|
Changes of C reactive protein
Time Frame: 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
|
0, 4, 8,12 weeks
|
Changes of Interleukin-1β,Interleukin-6,tumor necrosis factor(TNF-α)
Time Frame: 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
|
0, 4, 8,12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ber-Met-MS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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