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

NCT02936414 | Completed DMC

• 1 other identifier: Ber-2015-TJAH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Berberine; Cytokine; CRP; Metabolism; Schizophrenia

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• The change of clinical symptoms assessed with The Positive and Negative Syndrome Scale

  Change from Baseline clinical symptoms at 12 weeks

• Adverse event

  At 12 weeks

Study Arms (2)

Berberine group

EXPERIMENTAL

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

Drug: Berberine

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Berberine DRUG

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

Also known as: Huang Liansu, Rhizoma coptidis

Berberine group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Anding Hospital: lead

Study Sites (1)

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300222, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Berberine; Coptidis rhizoma extract

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 18, 2016
• Study Start: July 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 17, 2018

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)