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

Not Applicable

Completed

• Conditions: Schizophrenia; Therapeutics
• Interventions: Drug: Berberine; Drug: atypical antipsychotic; Drug: placebo

• Registration Number: NCT03548155
• Lead Sponsor: Tianjin Anding Hospital

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).

Study Timeline

• Study Start: 2014-07-24
• Primary Completion: 2015-12-14
• Study Completion: 2017-05-08
• Status Verified: 2018-05
• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-06-07
• Last Update Submitted: 2023-07-22
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
berberine group	atypical antipsychotic	-
control group	atypical antipsychotic	-
control group	placebo	-
berberine group	Berberine	-

Primary Outcome Measures

Name	Time	Method
Changes of negative symptoms	changes within 0,4,8weeks	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

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