Berberine Effects on Clinical Symptoms and Metabolic Disturbance in Patients With Schizophrenia
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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
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At least 60 for Positive and Negative Syndrome Scale (PANSS)
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Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential
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Sign the informed consent form
Exclusion Criteria:
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Individuals who with diagnosis of other psychiatric disorders except schizophrenia according to DSM-IV
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Refused to provide informed consent
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tianjin Anding Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BBR-SCH-2015