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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03548155
• Other study ID #: BBR-SCH-2015
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Schizophrenia
• Therapeutics

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