Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berberine group | Experimental | Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy. |
|
| Placebo group | Placebo Comparator | Accept placebo(300 mg/tid)+SGAs monotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine | Drug | Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of glucose | Change from Baseline Glucose at 12 weeks | |
| The change of insulin | Change from Baseline insulin at 12 weeks | |
| The change of HbA1c | Change from Baseline HbA1c at 12 weeks | |
| The change of lipid profile | Change from Baseline lipid profile at 12 weeks | |
| The change of CRP | Change from Baseline CRP at 12 weeks | |
| The change of IL-1β | Change from Baseline IL-1β at 12 weeks | |
| The change of IL-6 | Change from Baseline IL-6 at 12 weeks | |
| The change of TNF-α | 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 | Change from Baseline Cognitive function at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change of clinical symptoms assessed with The Positive and Negative Syndrome Scale | The Positive and Negative Syndrome Scale for clinical symptoms | Change from Baseline clinical symptoms at 12 weeks |
| Adverse event |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Anding Hospital | Tianjin | Tianjin Municipality | 300222 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D001599 | Berberine |
| C107393 | Coptidis rhizoma extract |
| ID | Term |
|---|---|
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Accept placebo(300 mg/tid)+SGAs monotherapy. |
|
| At 12 weeks |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |