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

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936414
• Other study ID #: Ber-2015-TJAH
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Tianjin Anding Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Berberine
Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy.
• Placebo
Accept placebo(300 mg/tid)+SGAs monotherapy.

Locations

Country	Name	City	State
China	Tianjin Anding Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Anding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of glucose		Change from Baseline Glucose at 12 weeks
Primary	The change of insulin		Change from Baseline insulin at 12 weeks
Primary	The change of HbA1c		Change from Baseline HbA1c at 12 weeks
Primary	The change of lipid profile		Change from Baseline lipid profile at 12 weeks
Primary	The change of CRP		Change from Baseline CRP at 12 weeks
Primary	The change of IL-1ß		Change from Baseline IL-1ß at 12 weeks
Primary	The change of IL-6		Change from Baseline IL-6 at 12 weeks
Primary	The change of TNF-a		Change from Baseline TNF-a at 12 weeks
Primary	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	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
Secondary	Adverse event		At 12 weeks