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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03548155
Other study ID # BBR-SCH-2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 24, 2014
Est. completion date May 8, 2017

Study information

Verified date May 2018
Source Tianjin Anding Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date May 8, 2017
Est. primary completion date December 14, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 62 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Berberine
Berberine 300mg(three times a day) plus any atypical antipsychotic drug
atypical antipsychotic
Any atypical antipsychotic drug as the basic treatment
placebo
The placebo were matched to Berberine in shape, smell and colour and capsules were sealed in identical bottles

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Anding Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of negative symptoms 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. changes within 0,4,8weeks
Secondary Changes of Fasting blood samples for Fasting blood glucose(FBG) The levels of FBG has been obtained at 3 point intervals: 0, 4, 8 weeks changes within 0,4,8 weeks
Secondary Changes of Insulin The levels of Insulin has been obtained at 3 point intervals: 0, 4, 8 weeks changes within 0,4,8 weeks
Secondary Changes of TC The levels of TC has been obtained at 3 point intervals: 0, 4, 8 weeks changes within 0,4,8 weeks
Secondary Changes of TG The levels of TG has been obtained at 3 point intervals: 0, 4, 8 weeks changes within 0,4,8weeks
Secondary Changes of HDL-C The levels of HDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks changes within 0,4,8weeks
Secondary Changes of LDL-C The levels of LDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks changes within 0,4,8weeks
Secondary Safety Evaluate the safety of berberine changes within 0,4,8weeks
Secondary Changes of CRP The levels of CRP has been obtained at 3 point intervals: 0, 4, 8 weeks changes within 0,4,8weeks
Secondary Changes of IL-1ß The levels of IL-1ß has been obtained at 3 point intervals: 0, 4, 8 weeks changes within 0,4,8weeks
Secondary Changes of IL-6 The levels of IL-6 has been obtained at 3 point intervals: 0, 4, 8 weeks changes within 0,4,8weeks
Secondary Changes of TNF-a The levels of TNF-a has been obtained at 3 point intervals: 0, 4, 8 weeks changes within 0,4,8weeks
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