Clinical trial NCT03548155: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Therapeutics
Keywords: schizophrenia；berberine；symptoms；inflammation
Lead sponsor: Tianjin Anding Hospital
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Changes of negative symptoms
timeFrame: changes within 0,4,8weeks
Secondary outcomes:
measure: Changes of Fasting blood samples for Fasting blood glucose(FBG)
timeFrame: changes within 0,4,8 weeks
measure: Changes of Insulin
timeFrame: changes within 0,4,8 weeks
measure: Changes of TC
timeFrame: changes within 0,4,8 weeks
measure: Changes of TG
timeFrame: changes within 0,4,8weeks
measure: Changes of HDL-C
timeFrame: changes within 0,4,8weeks
measure: Changes of LDL-C
timeFrame: changes within 0,4,8weeks
measure: Safety
timeFrame: changes within 0,4,8weeks
measure: Changes of CRP
timeFrame: changes within 0,4,8weeks
measure: Changes of IL-1β
timeFrame: changes within 0,4,8weeks
measure: Changes of IL-6
timeFrame: changes within 0,4,8weeks
measure: Changes of TNF-α
timeFrame: changes within 0,4,8weeks
Other outcomes:
Locations:
Study officials:
References:
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.