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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Berberine
Placebo
Sponsored by
Tianjin Anding Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Berberine, Cytokine, CRP, Metabolism, Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tianjin Anding Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Berberine group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The change of glucose
The change of insulin
The change of HbA1c
The change of lipid profile
The change of CRP
The change of IL-1β
The change of IL-6
The change of TNF-α
The change of Cognitive function assessed with The MATRICS Consensus Cognitive Battery (MCCB)
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
The Positive and Negative Syndrome Scale for clinical symptoms
Adverse event

Full Information

First Posted
September 29, 2016
Last Updated
May 13, 2018
Sponsor
Tianjin Anding Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02936414
Brief Title
Berberine Effect on Cytokine, CRP, Metabolic Disturbance as an Adjunctive Therapy in Schizophrenia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Anding Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Berberine, Cytokine, CRP, Metabolism, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Berberine group
Arm Type
Experimental
Arm Description
Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Accept placebo(300 mg/tid)+SGAs monotherapy.
Intervention Type
Drug
Intervention Name(s)
Berberine
Other Intervention Name(s)
Huang Liansu, Rhizoma coptidis
Intervention Description
Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Accept placebo(300 mg/tid)+SGAs monotherapy.
Primary Outcome Measure Information:
Title
The change of glucose
Time Frame
Change from Baseline Glucose at 12 weeks
Title
The change of insulin
Time Frame
Change from Baseline insulin at 12 weeks
Title
The change of HbA1c
Time Frame
Change from Baseline HbA1c at 12 weeks
Title
The change of lipid profile
Time Frame
Change from Baseline lipid profile at 12 weeks
Title
The change of CRP
Time Frame
Change from Baseline CRP at 12 weeks
Title
The change of IL-1β
Time Frame
Change from Baseline IL-1β at 12 weeks
Title
The change of IL-6
Time Frame
Change from Baseline IL-6 at 12 weeks
Title
The change of TNF-α
Time Frame
Change from Baseline TNF-α at 12 weeks
Title
The change of Cognitive function assessed with The MATRICS Consensus Cognitive Battery (MCCB)
Description
The MATRICS Consensus Cognitive Battery (MCCB) for Cognitive function
Time Frame
Change from Baseline Cognitive function at 12 weeks
Secondary Outcome Measure Information:
Title
The change of clinical symptoms assessed with The Positive and Negative Syndrome Scale
Description
The Positive and Negative Syndrome Scale for clinical symptoms
Time Frame
Change from Baseline clinical symptoms at 12 weeks
Title
Adverse event
Time Frame
At 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tianjin Anding Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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