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

Berberine Effects on Clinical Symptoms and Metabolic Disturbance as an Adjunctive Therapy in Patients With Schizophrenia: a Randomized Double-blind Placebo-controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Therapeutics
• Intervention / Treatment: Drug: Berberine; Drug: atypical antipsychotic; Drug: placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 62 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group	Drug: atypical antipsychotic; Any atypical antipsychotic drug as the basic treatment; Drug: placebo; The placebo were matched to Berberine in shape, smell and colour and capsules were sealed in identical bottles
Experimental: berberine group	Drug: Berberine; Berberine 300mg（three times a day） plus any atypical antipsychotic drug; Drug: atypical antipsychotic; Any atypical antipsychotic drug as the basic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	changes within 0,4,8weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 within 0,4,8 weeks
Changes of Insulin	The levels of Insulin has been obtained at 3 point intervals: 0, 4, 8 weeks	changes within 0,4,8 weeks
Changes of TC	The levels of TC has been obtained at 3 point intervals: 0, 4, 8 weeks	changes within 0,4,8 weeks
Changes of TG	The levels of TG has been obtained at 3 point intervals: 0, 4, 8 weeks	changes within 0,4,8weeks
Changes of HDL-C	The levels of HDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks	changes within 0,4,8weeks
Changes of LDL-C	The levels of LDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks	changes within 0,4,8weeks
Safety	Evaluate the safety of berberine	changes within 0,4,8weeks
Changes of CRP	The levels of CRP has been obtained at 3 point intervals: 0, 4, 8 weeks	changes within 0,4,8weeks
Changes of IL-1β	The levels of IL-1β has been obtained at 3 point intervals: 0, 4, 8 weeks	changes within 0,4,8weeks
Changes of IL-6	The levels of IL-6 has been obtained at 3 point intervals: 0, 4, 8 weeks	changes within 0,4,8weeks
Changes of TNF-α	The levels of TNF-α has been obtained at 3 point intervals: 0, 4, 8 weeks	changes within 0,4,8weeks

Collaborators and Investigators

• Sponsor: Tianjin Anding Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2014
• Primary Completion (Actual): December 14, 2015
• Study Completion (Actual): May 8, 2017

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 22, 2023
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: schizophrenia；berberine；symptoms；inflammation
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antipsychotic Agents
• Other Study ID Numbers: BBR-SCH-2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No