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

Last updated: February 14, 2022
Sponsor: Tianjin Anding Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Metabolic Syndrome

Tourette's Syndrome

Metabolic Disorders

Treatment

N/A

Clinical Study ID

NCT03708549
Ber-Met-MS
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. In accordance with criteria set out in the Structured Clinical Interview forDiagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV )Axis IDisorders, Clinical Version;
  • 2)Meet metabolic syndrome based on Guidelines for Prevention and Treatment of BloodLipid Abnormality in Chinese Adults(2007);
  • 3)Have taken stable dose of the current single antipsychotic drug for at least onemonth;
    1. Female subjects will be enrolled to participate in the study if they are ofnon-childbearing potential or of child-bearing potential and willing to practiceappropriate birth control methods during the study.

Exclusion

Exclusion Criteria:

  • 1)Individuals who refuse to provide informed consent;
  • 2)Currently substance abuse or psychiatrically unstable per treating clinician'sjudgment;
  • 3)One with significant medical illnesses including uncontrolled hypertension,diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, orthyroid diseases also not suitable for this trial;
  • 4)Currently on anti-inflammatory or immunosuppressant medication including oralsteroids and history of chronic infection (including tuberculosis, HIV and hepatitis),malignancy, organ transplantation, blood dyscrasia, central nervous systemdemyelinating disorder, and any other known autoimmune or inflammatory conditionpregnancy or breastfeeding.

Study Design

Total Participants: 100
Study Start date:
December 01, 2021
Estimated Completion Date:
December 01, 2023

Connect with a study center

  • Tianjin Anding Hospital

    Tianjin, Tianjin 300222
    China

    Active - Recruiting

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