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

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ClinicalTrials.gov Identifier: NCT03708549
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Metabolic Syndrome Berberine Metformin Drug: Berberine Drug: Metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of Berberine and Metformin for Schizophrenia Patients With Metabolic Syndrome
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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

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

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

Drug: 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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708549


Contacts
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Contact: Jie Li, PHD 022-88188006 tjlijie3827@163.com

Locations
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China, Tianjin
Tianjin Anding Hospital Recruiting
Tianjin, Tianjin, China, 300222
Contact: Jie Li, Doctor    +86 022 88188006    tjlijie3827@163.com   
Sponsors and Collaborators
Tianjin Anding Hospital

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Responsible Party: Tianjin Anding Hospital
ClinicalTrials.gov Identifier: NCT03708549     History of Changes
Other Study ID Numbers: Ber-Met-MS
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tianjin Anding Hospital:
Berberine
Metformin
Metabolic syndrome
Schizophrenia

Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Schizophrenia
Disease
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Antipsychotic Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs