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

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ClinicalTrials.gov Identifier: NCT03548155
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Tianjin Anding Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Therapeutics Drug: Berberine Drug: atypical antipsychotic Drug: placebo Phase 4

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Berberine Effects on Clinical Symptoms and Metabolic Disturbance as an Adjunctive Therapy in Patients With Schizophrenia: a Randomized Double-blind Placebo-controlled Study
Actual Study Start Date : July 24, 2014
Actual Primary Completion Date : December 14, 2015
Actual Study Completion Date : May 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: berberine group Drug: Berberine
Berberine 300mg(three times a day) plus any atypical antipsychotic drug

Drug: atypical antipsychotic
Any atypical antipsychotic drug as the basic treatment

Placebo Comparator: control group Drug: atypical antipsychotic
Any atypical antipsychotic drug as the basic treatment

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




Primary Outcome Measures :
  1. Changes of negative symptoms [ Time Frame: changes within 0,4,8weeks ]
    Positive and Negative Syndrome Scale(PANSS)has been used to assess symptom severity in schizophrenia.Of the items included in PANSS ,seven constitute a Positive scale,seven form a Negative scale and sixteen constitute a General Psychopathology scale.7-point rating instrument was conceived.A total Score is computed three subscales.Minimum scores is 30 and maximum scores is 210.The higher score are considered the psychiatric symptoms more serious.


Secondary Outcome Measures :
  1. Changes of Fasting blood samples for Fasting blood glucose(FBG) [ Time Frame: changes within 0,4,8 weeks ]
    The levels of FBG has been obtained at 3 point intervals: 0, 4, 8 weeks

  2. Changes of Insulin [ Time Frame: changes within 0,4,8 weeks ]
    The levels of Insulin has been obtained at 3 point intervals: 0, 4, 8 weeks

  3. Changes of TC [ Time Frame: changes within 0,4,8 weeks ]
    The levels of TC has been obtained at 3 point intervals: 0, 4, 8 weeks

  4. Changes of TG [ Time Frame: changes within 0,4,8weeks ]
    The levels of TG has been obtained at 3 point intervals: 0, 4, 8 weeks

  5. Changes of HDL-C [ Time Frame: changes within 0,4,8weeks ]
    The levels of HDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks

  6. Changes of LDL-C [ Time Frame: changes within 0,4,8weeks ]
    The levels of LDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks

  7. Safety [ Time Frame: changes within 0,4,8weeks ]
    Evaluate the safety of berberine

  8. Changes of CRP [ Time Frame: changes within 0,4,8weeks ]
    The levels of CRP has been obtained at 3 point intervals: 0, 4, 8 weeks

  9. Changes of IL-1β [ Time Frame: changes within 0,4,8weeks ]
    The levels of IL-1β has been obtained at 3 point intervals: 0, 4, 8 weeks

  10. Changes of IL-6 [ Time Frame: changes within 0,4,8weeks ]
    The levels of IL-6 has been obtained at 3 point intervals: 0, 4, 8 weeks

  11. Changes of TNF-α [ Time Frame: changes within 0,4,8weeks ]
    The levels of TNF-α has been obtained at 3 point intervals: 0, 4, 8 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Tianjin Anding Hospital
ClinicalTrials.gov Identifier: NCT03548155     History of Changes
Other Study ID Numbers: BBR-SCH-2015
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tianjin Anding Hospital:
schizophrenia;berberine;symptoms;inflammation

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs