Berberine Effect on Cytokine, CRP, Metabolic Disturbance as an Adjunctive Therapy in Schizophrenia Patients

Sponsor

Tianjin Anding Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02936414

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Berberine Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Berberine group Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy.	Drug: Berberine Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy. Other Names: Huang Liansu Rhizoma coptidis
Placebo Comparator: Placebo group Accept placebo(300 mg/tid)+SGAs monotherapy.	Drug: Placebo Accept placebo(300 mg/tid)+SGAs monotherapy.

Arm

Intervention/Treatment

Experimental: Berberine group

Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy.

Drug: Berberine

Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy.

Other Names:

Huang Liansu

Rhizoma coptidis

Placebo Comparator: Placebo group

Accept placebo(300 mg/tid)+SGAs monotherapy.

Drug: Placebo

Accept placebo(300 mg/tid)+SGAs monotherapy.

Outcome Measures

Primary Outcome Measures

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) [Change from Baseline Cognitive function at 12 weeks]
The MATRICS Consensus Cognitive Battery (MCCB) for Cognitive function

Secondary Outcome Measures

The change of clinical symptoms assessed with The Positive and Negative Syndrome Scale [Change from Baseline clinical symptoms at 12 weeks]
The Positive and Negative Syndrome Scale for clinical symptoms
Adverse event [At 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Individuals who age 18 to 60 years diagnose schizophrenia according the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID).
The patients have illness for less than 5 years and have stable dose of the current antipsychotic drug for at least one month.
Well established compliance with inpatient treatment per treating clinician's judgment. On baseline, at least 60 for Positive and Negative Syndrome Scale (PANSS) total score.
Able to complete the cognitive assessment battery Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.

Exclusion Criteria:

Individuals who refuse to provide informed consent.
Currently substance abuse or psychiatrically unstable per treating clinician's judgment.
One with significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases also not suitable for this trial.
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 pregnancy or breastfeeding.