NCT03548155

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2014

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

July 24, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2015

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
Last Updated

July 25, 2023

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

May 14, 2018

Last Update Submit

July 22, 2023

Conditions

SchizophreniaTherapeutics

Keywords

schizophrenia；berberine；symptoms；inflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Changes of Fasting blood samples for Fasting blood glucose(FBG)

    changes within 0,4,8 weeks

  • Changes of Insulin

    changes within 0,4,8 weeks

  • Changes of TC

    changes within 0,4,8 weeks

  • Changes of TG

    changes within 0,4,8weeks

  • Changes of HDL-C

    changes within 0,4,8weeks

  • +6 more secondary outcomes

Study Arms (2)

berberine group

EXPERIMENTAL
Drug: BerberineDrug: atypical antipsychotic

control group

PLACEBO COMPARATOR
Drug: atypical antipsychoticDrug: placebo

Interventions

BerberineDRUG

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

berberine group
atypical antipsychoticDRUG

Any atypical antipsychotic drug as the basic treatment

berberine groupcontrol group
placeboDRUG

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

control group

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Li M, Qiu Y, Zhang J, Zhang Y, Liu Y, Zhao Y, Jia Q, Fan X, Li J. Improvement of adjunctive berberine treatment on negative symptoms in patients with schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2022 Jun;272(4):633-642. doi: 10.1007/s00406-021-01359-4. Epub 2022 Jan 17.

    PMID: 35037116DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Berberine

Condition Hierarchy (Ancestors)

Schizophrenia 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
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

June 7, 2018

Study Start

July 24, 2014

Primary Completion

December 14, 2015

Study Completion

May 8, 2017

Last Updated

July 25, 2023

Record last verified: 2018-05