search
Back to results

Berberine Effects on Clinical Symptoms and Metabolic Disturbance in Patients With Schizophrenia

Primary Purpose

Schizophrenia, Therapeutics

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Berberine
atypical antipsychotic
placebo
Sponsored by
Tianjin Anding Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia；berberine；symptoms；inflammation

Eligibility Criteria

18 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals who aged 18 to 65 years
  • Meet the diagnosis of schizophrenia according to DSM-IV
  • Monotherapy of atypical antipsychotics for 4 weeks or more
  • At least 60 for Positive and Negative Syndrome Scale (PANSS)
  • Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential
  • Sign the informed consent form

Exclusion Criteria:

  • Individuals who with diagnosis of other psychiatric disorders except schizophrenia according to DSM-IV
  • Refused to provide informed consent
  • Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    berberine group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes of negative symptoms
    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.

    Secondary Outcome Measures

    Changes of Fasting blood samples for Fasting blood glucose(FBG)
    The levels of FBG has been obtained at 3 point intervals: 0, 4, 8 weeks
    Changes of Insulin
    The levels of Insulin has been obtained at 3 point intervals: 0, 4, 8 weeks
    Changes of TC
    The levels of TC has been obtained at 3 point intervals: 0, 4, 8 weeks
    Changes of TG
    The levels of TG has been obtained at 3 point intervals: 0, 4, 8 weeks
    Changes of HDL-C
    The levels of HDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks
    Changes of LDL-C
    The levels of LDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks
    Safety
    Evaluate the safety of berberine
    Changes of CRP
    The levels of CRP has been obtained at 3 point intervals: 0, 4, 8 weeks
    Changes of IL-1β
    The levels of IL-1β has been obtained at 3 point intervals: 0, 4, 8 weeks
    Changes of IL-6
    The levels of IL-6 has been obtained at 3 point intervals: 0, 4, 8 weeks
    Changes of TNF-α
    The levels of TNF-α has been obtained at 3 point intervals: 0, 4, 8 weeks

    Full Information

    First Posted
    May 14, 2018
    Last Updated
    July 22, 2023
    Sponsor
    Tianjin Anding Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03548155
    Brief Title
    Berberine Effects on Clinical Symptoms and Metabolic Disturbance in Patients With Schizophrenia
    Official Title
    Berberine Effects on Clinical Symptoms and Metabolic Disturbance as an Adjunctive Therapy in Patients With Schizophrenia: a Randomized Double-blind Placebo-controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 24, 2014 (Actual)
    Primary Completion Date
    December 14, 2015 (Actual)
    Study Completion Date
    May 8, 2017 (Actual)

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study was a 8-week, randomized, double-blind, placebo-controlled trial. Berberine (300 mg，three times a day), as an adjuvant therapy has been used on the basis of the Second-generation antipsychotics（SGAs） monotherapy. All participants were randomly divided into two groups.Any SGA + berberine (BBR) or any SGA +placebo.Positive and Negative Syndrome Scale (PANSS) has been used for psychiatric symptoms.The treatment Emergent Symptom Scale(TESS) has been used for evaluate adverse effects.Glucose and lipid profile, inflammatory factors，adiponectin，leptin were obtained at 0, 4,8 weeks.
    Detailed Description
    Glucose and lipid profile:Fasting blood samples for Fasting blood glucose(FBG),Insulin, Hemoglobin A1c(HbA1c), Total cholesterol(TC), Low-density lipoprotein cholesterol(LDL-C),High-density lipoprotein cholesterol(HDL-C), Triglycerides (TG),Apolipoprotein A(ApoA),Apolipoprotein B(ApoB),Lipoprotein-a(Lp-a) . Inflammatory factors:C-reaction protein(CRP),Interleukine-1 beta(IL-1β), Interleukine-6 (IL-6), Tumor necrosis factor-α (TNF-α).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Therapeutics
    Keywords
    schizophrenia；berberine；symptoms；inflammation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    berberine group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Berberine
    Intervention Description
    Berberine 300mg（three times a day） plus any atypical antipsychotic drug
    Intervention Type
    Drug
    Intervention Name(s)
    atypical antipsychotic
    Intervention Description
    Any atypical antipsychotic drug as the basic treatment
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    The placebo were matched to Berberine in shape, smell and colour and capsules were sealed in identical bottles
    Primary Outcome Measure Information:
    Title
    Changes of negative symptoms
    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.
    Time Frame
    changes within 0,4,8weeks
    Secondary Outcome Measure Information:
    Title
    Changes of Fasting blood samples for Fasting blood glucose(FBG)
    Description
    The levels of FBG has been obtained at 3 point intervals: 0, 4, 8 weeks
    Time Frame
    changes within 0,4,8 weeks
    Title
    Changes of Insulin
    Description
    The levels of Insulin has been obtained at 3 point intervals: 0, 4, 8 weeks
    Time Frame
    changes within 0,4,8 weeks
    Title
    Changes of TC
    Description
    The levels of TC has been obtained at 3 point intervals: 0, 4, 8 weeks
    Time Frame
    changes within 0,4,8 weeks
    Title
    Changes of TG
    Description
    The levels of TG has been obtained at 3 point intervals: 0, 4, 8 weeks
    Time Frame
    changes within 0,4,8weeks
    Title
    Changes of HDL-C
    Description
    The levels of HDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks
    Time Frame
    changes within 0,4,8weeks
    Title
    Changes of LDL-C
    Description
    The levels of LDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks
    Time Frame
    changes within 0,4,8weeks
    Title
    Safety
    Description
    Evaluate the safety of berberine
    Time Frame
    changes within 0,4,8weeks
    Title
    Changes of CRP
    Description
    The levels of CRP has been obtained at 3 point intervals: 0, 4, 8 weeks
    Time Frame
    changes within 0,4,8weeks
    Title
    Changes of IL-1β
    Description
    The levels of IL-1β has been obtained at 3 point intervals: 0, 4, 8 weeks
    Time Frame
    changes within 0,4,8weeks
    Title
    Changes of IL-6
    Description
    The levels of IL-6 has been obtained at 3 point intervals: 0, 4, 8 weeks
    Time Frame
    changes within 0,4,8weeks
    Title
    Changes of TNF-α
    Description
    The levels of TNF-α has been obtained at 3 point intervals: 0, 4, 8 weeks
    Time Frame
    changes within 0,4,8weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    62 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Individuals who aged 18 to 65 years Meet the diagnosis of schizophrenia according to DSM-IV Monotherapy of atypical antipsychotics for 4 weeks or more At least 60 for Positive and Negative Syndrome Scale (PANSS) Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential Sign the informed consent form Exclusion Criteria: Individuals who with diagnosis of other psychiatric disorders except schizophrenia according to DSM-IV Refused to provide informed consent Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35037116
    Citation
    Li M, Qiu Y, Zhang J, Zhang Y, Liu Y, Zhao Y, Jia Q, Fan X, Li J. Improvement of adjunctive berberine treatment on negative symptoms in patients with schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2022 Jun;272(4):633-642. doi: 10.1007/s00406-021-01359-4. Epub 2022 Jan 17.
    Results Reference
    derived

    Learn more about this trial

    Berberine Effects on Clinical Symptoms and Metabolic Disturbance in Patients With Schizophrenia

    We'll reach out to this number within 24 hrs