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

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 Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Berberine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300222
      • Tianjin Anding Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		At 12 weeks

Collaborators and Investigators

• Sponsor: Tianjin Anding Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 13, 2018
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Schizophrenia; Cytokine; Metabolism; Berberine; CRP
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: Ber-2015-TJAH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO