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Completed

NCT Number: NCT03251716

Berberine Treat Metabolic Syndrome in Schizophrenia

In early clinical study investigators confirmed that berberine could prevent glucose and lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and safety of berberine in treatment for metabolic syndrome in schizophrenia.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300222, China

About this study

This study is an open lable clinical intervention trial, include 30 female subjects with diagnosis of schizophrenia and metabolic syndrome.Participants will be given berberine( 300mgTID) as an add-on therapy lasting 8 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • subjects with the diagnosis of schizophrenia depend on Statistical Manual, Fifth Edition (DSM-5) ;
  • Female subjects aged 18-60 years;
  • monotherapy of atypical antipsychotics for 2 weeks or more , including olanzapine, clozapine, risperidone, and perphenazine;
  • subjects with diagnosis of metabolic syndrome depending on guidelines for the prevention and treatment of dyslipidemia in Chinese adults in 2007;
  • the subjects and their guardians sign the informed consent agreement.

Exclusion criteria

  • subjects with diagnosis of other psychiatric disorders except schizophrenia depend on DSM-5;
  • chronic organic diseases involving any central nervous system, such as tumors and inflammation, brain trauma, active seizures, vascular diseases, Parkinson's disease, myasthenia gravis, and other degenerative diseases;
  • a history of gastrointestinal surgery or the presence of any possibility of interfering with the absorption, distribution, metabolism, or excretion of drugs situation;
  • used long-acting antipsychotic drugs or receive electroconvulsive therapy (MECT) or receive transcranial magnetic stimulation therapy in the last 1 months;
  • serious physical diseases, including uncontrolled hypertension, severe cardiovascular, cerebrovascular, and pulmonary diseases, thyroid diseases, etc;
  • currently receiving anti-inflammatory or immunosuppressive treatment, including oral steroids;
  • a history of chronic infection, including tuberculosis, AIDS and hepatitis;
  • allergic to berberine,or hemolytic anemia or glucose -6- phosphate dehydrogenase deficiency;
  • pregnant women, lactating women;
  • participants were involved in other clinical trials within 1 months prior to the signing of informed consent
  • other reasons judged by the researchers to be inappropriate for the clinical study.

Treatment and study plan

Berberine

Drug

berberine 300mg TID add-on for berberine adjunctive group

Other names: berberine hydrochloride

Primary outcomes

  1. Change of FBG

    Time frame: Change from Baseline serum fasting biood glucose at 8 weeks

    Serum fasting biood glucose

Secondary outcomes

  1. Change of TG

    Time frame: Change from Baseline serum triglyceride at 8 weeks

    Serum triglyceride

  2. Change of LDL

    Time frame: Change from Baseline serum low density lipoprotein at 8 weeks

    Serum low density lipoprotein

  3. Change of BP

    Time frame: Change from Baseline Systolic Blood Pressure at 8 weeks

    Systolic blood pressure

  4. Change of waist

    Time frame: Change from Baseline waistline at 8 weeks

    Waistline

  5. Change of BP

    Time frame: Change from Baseline Diastolic Blood Pressure at 8 weeks

    Diastolic blood pressure

Sponsors and collaborators

Lead sponsor

Tianjin Anding Hospital

Other

Registry information

Official study title

Berberine in the Treatment of Metabolic Syndrome : an Open Label Clinical Study in Female Schizophrenia Patients

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 16, 2017
Registry last updated
Apr 25, 2018

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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