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Completed

NCT Number: NCT02936414

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300222, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Berberine

Drug

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

Drug

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

Primary outcomes

  1. The change of glucose

    Time frame: Change from Baseline Glucose at 12 weeks

  2. The change of insulin

    Time frame: Change from Baseline insulin at 12 weeks

  3. The change of HbA1c

    Time frame: Change from Baseline HbA1c at 12 weeks

  4. The change of lipid profile

    Time frame: Change from Baseline lipid profile at 12 weeks

  5. The change of CRP

    Time frame: Change from Baseline CRP at 12 weeks

  6. The change of IL-1β

    Time frame: Change from Baseline IL-1β at 12 weeks

  7. The change of IL-6

    Time frame: Change from Baseline IL-6 at 12 weeks

  8. The change of TNF-α

    Time frame: Change from Baseline TNF-α at 12 weeks

  9. The change of Cognitive function assessed with The MATRICS Consensus Cognitive Battery (MCCB)

    Time frame: Change from Baseline Cognitive function at 12 weeks

    The MATRICS Consensus Cognitive Battery (MCCB) for Cognitive function

Secondary outcomes

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

    Time frame: Change from Baseline clinical symptoms at 12 weeks

    The Positive and Negative Syndrome Scale for clinical symptoms

  2. Adverse event

    Time frame: At 12 weeks

Sponsors and collaborators

Lead sponsor

Tianjin Anding Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2016
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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