NCT03251716

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

April 25, 2018

Status Verified

December 1, 2017

Enrollment Period

2.8 years

First QC Date

August 3, 2017

Last Update Submit

April 24, 2018

Conditions

Metabolic SyndromeFemaleSchizophrenia

Keywords

Metabolic syndromeSchizophreniaEfficacyFemaleBerberine

Outcome Measures

Primary Outcomes (1)

  • Change of FBG

    Serum fasting biood glucose

    Change from Baseline serum fasting biood glucose at 8 weeks

Secondary Outcomes (5)

  • Change of TG

    Change from Baseline serum triglyceride at 8 weeks

  • Change of LDL

    Change from Baseline serum low density lipoprotein at 8 weeks

  • Change of BP

    Change from Baseline Systolic Blood Pressure at 8 weeks

  • Change of waist

    Change from Baseline waistline at 8 weeks

  • Change of BP

    Change from Baseline Diastolic Blood Pressure at 8 weeks

Study Arms (1)

berberine adjunctive group

EXPERIMENTAL

Only one treatment group in this study, without a preset control group,subjects who meet the criteria will entere the berberine adjunctive group

Drug: berberine

Interventions

berberineDRUG

berberine 300mg TID add-on for berberine adjunctive group

Also known as: berberine hydrochloride
berberine adjunctive group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300222, China

Location

MeSH Terms

Conditions

Metabolic SyndromeSchizophrenia

Interventions

Berberine

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Berberine AlkaloidsBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 16, 2017

Study Start

January 1, 2015

Primary Completion

October 30, 2017

Study Completion

December 30, 2017

Last Updated

April 25, 2018

Record last verified: 2017-12

Locations

CN(1)