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SchizophreniaNCT03548155

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

A study testing Berberine and atypical antipsychotic in people with Schizophrenia and Therapeutics, run by Tianjin Anding Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 62 years
Conditions the study is for
Schizophrenia, Therapeutics
What is being tested?
Berberine and atypical antipsychotic
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
No sites listed yet
Study dates
24 Jul 2014to 8 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 62 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

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

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.

Read the detailed 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).

Being tested
Berberine, atypical antipsychotic, placebo
Keywords
schizophrenia；berberine；symptoms；inflammation
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BerberineDrug

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

  • atypical antipsychoticDrug

    Any atypical antipsychotic drug as the basic treatment

  • placeboDrug

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

Study groups in NCT03548155
Study groupRoleWhat they receive
berberine groupExperimentalNot described
Receives: Drug: Berberine; Drug: atypical antipsychotic
control groupPlacebo comparatorNot described
Receives: Drug: atypical antipsychotic; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: changes within 0,4,8weeks

Secondary outcomes (11)

  1. 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

    Measured: changes within 0,4,8 weeks

  2. Changes of Insulin

    The levels of Insulin has been obtained at 3 point intervals: 0, 4, 8 weeks

    Measured: changes within 0,4,8 weeks

  3. Changes of TC

    The levels of TC has been obtained at 3 point intervals: 0, 4, 8 weeks

    Measured: changes within 0,4,8 weeks

  4. Changes of TG

    The levels of TG has been obtained at 3 point intervals: 0, 4, 8 weeks

    Measured: changes within 0,4,8weeks

  5. Changes of HDL-C

    The levels of HDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks

    Measured: changes within 0,4,8weeks

  6. Changes of LDL-C

    The levels of LDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks

    Measured: changes within 0,4,8weeks

  7. Safety

    Evaluate the safety of berberine

    Measured: changes within 0,4,8weeks

  8. Changes of CRP

    The levels of CRP has been obtained at 3 point intervals: 0, 4, 8 weeks

    Measured: changes within 0,4,8weeks

  9. Changes of IL-1β

    The levels of IL-1β has been obtained at 3 point intervals: 0, 4, 8 weeks

    Measured: changes within 0,4,8weeks

  10. Changes of IL-6

    The levels of IL-6 has been obtained at 3 point intervals: 0, 4, 8 weeks

    Measured: changes within 0,4,8weeks

  11. Changes of TNF-α

    The levels of TNF-α has been obtained at 3 point intervals: 0, 4, 8 weeks

    Measured: changes within 0,4,8weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2018
  2. Study start24 Jul 2014
  3. Primary completion14 Dec 2015
  4. Study completion8 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03548155
Sponsor's protocol ID
BBR-SCH-2015
Status last verified
May 2018
First submitted
14 May 2018
Last updated
25 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35037116

Questions about this trial

What is this clinical trial studying?

A study testing Berberine and atypical antipsychotic in people with Schizophrenia and Therapeutics, run by Tianjin Anding Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of negative symptoms (time frame: changes within 0,4,8weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03548155, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.

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