Berberine Effects on Clinical Symptoms and Metabolic Disturbance as an Adjunctive Therapy in Patients With Schizophrenia: a Randomized Double-blind Placebo-controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tianjin Anding Hospital
- Enrollment
- 65
- Primary Endpoint
- Changes of negative symptoms
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 62 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
berberine group
Intervention: Berberine (Drug)
berberine group
Intervention: atypical antipsychotic (Drug)
control group
Intervention: atypical antipsychotic (Drug)
control group
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Changes of negative symptoms
Time Frame: 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 Outcomes
- Changes of HDL-C(changes within 0,4,8weeks)
- Changes of LDL-C(changes within 0,4,8weeks)
- Safety(changes within 0,4,8weeks)
- Changes of Fasting blood samples for Fasting blood glucose(FBG)(changes within 0,4,8 weeks)
- Changes of Insulin(changes within 0,4,8 weeks)
- Changes of TC(changes within 0,4,8 weeks)
- Changes of TG(changes within 0,4,8weeks)
- Changes of CRP(changes within 0,4,8weeks)
- Changes of IL-1β(changes within 0,4,8weeks)
- Changes of IL-6(changes within 0,4,8weeks)
- Changes of TNF-α(changes within 0,4,8weeks)