The etiology and pathogenesis of schizophrenia remains unclear. Immune dysfunction hypothesis for schizophrenia has attracted increasing attention of the researchers, substantial evidences suggested the levels of C-reaction protein and cytokine such as IL-1β, IL-6, TNF-α markedly elevated in patients with schizophrenia which may be particularly relevant for the cognitive impairment and metabolic disturbance of schizophrenia. In recent years, it has been demonstrated the beneficial effects of berberine on regulating lipid and glucose metabolism, reducing the proinflammatory status and improving cognition. As the investigators known, the report of berberine being used in schizophrenia is rare. This protocol is aim to evaluate berberine, as an adjunctive therapy, on inflammatory markers, lipid and glucose metabolism, cognition in patients with schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy.
Accept placebo(300 mg/tid)+SGAs monotherapy.
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, China
The change of glucose
Time frame: Change from Baseline Glucose at 12 weeks
The change of insulin
Time frame: Change from Baseline insulin at 12 weeks
The change of HbA1c
Time frame: Change from Baseline HbA1c at 12 weeks
The change of lipid profile
Time frame: Change from Baseline lipid profile at 12 weeks
The change of CRP
Time frame: Change from Baseline CRP at 12 weeks
The change of IL-1β
Time frame: Change from Baseline IL-1β at 12 weeks
The change of IL-6
Time frame: Change from Baseline IL-6 at 12 weeks
The change of TNF-α
Time frame: Change from Baseline TNF-α at 12 weeks
The change of Cognitive function assessed with The MATRICS Consensus Cognitive Battery (MCCB)
The MATRICS Consensus Cognitive Battery (MCCB) for Cognitive function
Time frame: Change from Baseline Cognitive function at 12 weeks
The change of clinical symptoms assessed with The Positive and Negative Syndrome Scale
The Positive and Negative Syndrome Scale for clinical symptoms
Time frame: Change from Baseline clinical symptoms at 12 weeks
Adverse event
Time frame: At 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.