Berberine Effects on Clinical Symptoms and Metabolic Disturbance in Patients With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-24

Study Completion Date

2017-05-08

Brief Summary

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The study was a 8-week, randomized, double-blind, placebo-controlled trial. Berberine (300 mg，three times a day), as an adjuvant therapy has been used on the basis of the Second-generation antipsychotics（SGAs） monotherapy. All participants were randomly divided into two groups.Any SGA + berberine (BBR) or any SGA +placebo.Positive and Negative Syndrome Scale (PANSS) has been used for psychiatric symptoms.The treatment Emergent Symptom Scale(TESS) has been used for evaluate adverse effects.Glucose and lipid profile, inflammatory factors，adiponectin，leptin were obtained at 0, 4,8 weeks.

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Detailed Description

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Glucose and lipid profile:Fasting blood samples for Fasting blood glucose(FBG),Insulin, Hemoglobin A1c(HbA1c), Total cholesterol(TC), Low-density lipoprotein cholesterol(LDL-C),High-density lipoprotein cholesterol(HDL-C), Triglycerides (TG),Apolipoprotein A(ApoA),Apolipoprotein B(ApoB),Lipoprotein-a(Lp-a) .

Inflammatory factors:C-reaction protein(CRP),Interleukine-1 beta(IL-1β), Interleukine-6 (IL-6), Tumor necrosis factor-α (TNF-α).

Conditions

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Schizophrenia Therapeutics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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berberine group

Group Type EXPERIMENTAL

Berberine

Intervention Type DRUG

Berberine 300mg（three times a day） plus any atypical antipsychotic drug

atypical antipsychotic

Intervention Type DRUG

Any atypical antipsychotic drug as the basic treatment

control group

Group Type PLACEBO_COMPARATOR

atypical antipsychotic

Intervention Type DRUG

Any atypical antipsychotic drug as the basic treatment

placebo

Intervention Type DRUG

The placebo were matched to Berberine in shape, smell and colour and capsules were sealed in identical bottles

Interventions

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Berberine

Berberine 300mg（three times a day） plus any atypical antipsychotic drug

Intervention Type DRUG

atypical antipsychotic

Any atypical antipsychotic drug as the basic treatment

Intervention Type DRUG

placebo

The placebo were matched to Berberine in shape, smell and colour and capsules were sealed in identical bottles

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Individuals who aged 18 to 65 years
* Meet the diagnosis of schizophrenia according to DSM-IV
* Monotherapy of atypical antipsychotics for 4 weeks or more
* At least 60 for Positive and Negative Syndrome Scale (PANSS)
* Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential
* Sign the informed consent form

Exclusion Criteria

* Individuals who with diagnosis of other psychiatric disorders except schizophrenia according to DSM-IV
* Refused to provide informed consent
* Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No