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Completed

NCT Number: NCT03548155

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

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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Key information

Age range

18 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Berberine

Drug

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

atypical antipsychotic

Drug

Any atypical antipsychotic drug as the basic treatment

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tianjin Anding Hospital

Other

Registry information

Official study title

Berberine Effects on Clinical Symptoms and Metabolic Disturbance as an Adjunctive Therapy in Patients With Schizophrenia: a Randomized Double-blind Placebo-controlled Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jun 7, 2018
Registry last updated
Jul 25, 2023

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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