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