SchizophreniaNCT02936414
Berberine Effect on Cytokine, CRP, Metabolic Disturbance as an Adjunctive Therapy in Schizophrenia Patients
A study testing Berberine in people with Schizophrenia, run by Tianjin Anding Hospital at 1 site in China.
Trial summary
The etiology and pathogenesis of schizophrenia remains unclear. Immune dysfunction hypothesis for schizophrenia has attracted increasing attention of the researchers, substantial evidences suggested the levels of C-reaction protein and cytokine such as IL-1β, IL-6, TNF-α markedly elevated in patients with… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Berberine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Dec 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who age 18 to 60 years diagnose schizophrenia according the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID).
- The patients have illness for less than 5 years and have stable dose of the current antipsychotic drug for at least one month.
- Well established compliance with inpatient treatment per treating clinician's judgment. On baseline, at least 60 for Positive and Negative Syndrome Scale (PANSS) total score.
- Able to complete the cognitive assessment battery Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.
Who cannot join
- Individuals who refuse to provide informed consent.
- Currently substance abuse or psychiatrically unstable per treating clinician's judgment.
- One with significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases also not suitable for this trial.
- 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 pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
The etiology and pathogenesis of schizophrenia remains unclear. Immune dysfunction hypothesis for schizophrenia has attracted increasing attention of the researchers, substantial evidences suggested the levels of C-reaction protein and cytokine such as IL-1β, IL-6, TNF-α markedly elevated in patients with schizophrenia which may be particularly relevant for the cognitive impairment and metabolic disturbance of schizophrenia. In recent years, it has been demonstrated the beneficial effects of berberine on regulating lipid and glucose metabolism, reducing the proinflammatory status and improving cognition. As the investigators known, the report of berberine being used in schizophrenia is rare. This protocol is aim to evaluate berberine, as an adjunctive therapy, on inflammatory markers, lipid and glucose metabolism, cognition in patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Berberine, Placebo
- Keywords
- Berberine, Cytokine, CRP, Metabolism, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDrug
Also called Huang Liansu, Rhizoma coptidis
Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy.
PlaceboDrug
Accept placebo(300 mg/tid)+SGAs monotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Berberine group | Experimental | Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy. Receives: Drug: Berberine |
| Placebo group | Placebo comparator | Accept placebo(300 mg/tid)+SGAs monotherapy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of glucose
Measured: Change from Baseline Glucose at 12 weeks
The change of insulin
Measured: Change from Baseline insulin at 12 weeks
The change of HbA1c
Measured: Change from Baseline HbA1c at 12 weeks
The change of lipid profile
Measured: Change from Baseline lipid profile at 12 weeks
The change of CRP
Measured: Change from Baseline CRP at 12 weeks
The change of IL-1β
Measured: Change from Baseline IL-1β at 12 weeks
The change of IL-6
Measured: Change from Baseline IL-6 at 12 weeks
The change of TNF-α
Measured: Change from Baseline TNF-α at 12 weeks
The change of Cognitive function assessed with The MATRICS Consensus Cognitive Battery (MCCB)
The MATRICS Consensus Cognitive Battery (MCCB) for Cognitive function
Measured: Change from Baseline Cognitive function at 12 weeks
Secondary outcomes (2)
The change of clinical symptoms assessed with The Positive and Negative Syndrome Scale
The Positive and Negative Syndrome Scale for clinical symptoms
Measured: Change from Baseline clinical symptoms at 12 weeks
Adverse event
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJul 2014
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936414
- Sponsor's protocol ID
- Ber-2015-TJAH
- Status last verified
- Oct 2016
- First submitted
- 29 Sep 2016
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Berberine Effect on Cytokine, CRP, Metabolic Disturbance as an Adjunctive Therapy in Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT02936414
- Acronym / sponsor ID
- Ber-2015-TJAH
- Conditions
- Schizophrenia
- Keywords
- Berberine, Cytokine, CRP, Metabolism, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The etiology and pathogenesis of schizophrenia remains unclear. Immune dysfunction hypothesis for schizophrenia has attracted increasing attention of the researchers, substantial evidences suggested the levels of C-reaction protein and cytokine such as IL-1β, IL-6, TNF-α markedly elevated in patients with schizophrenia which may be particularly relevant for the cognitive impairment and metabolic disturbance of schizophrenia. In recent years, it has been demonstrated the beneficial effects of berberine on regulating lipid and glucose metabolism, reducing the proinflammatory status and improving cognition. As the investigators known, the report of berberine being used in schizophrenia is rare. This protocol is aim to evaluate berberine, as an adjunctive therapy, on inflammatory markers, lipid and glucose metabolism, cognition in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berberine group | Experimental | Drug: BerberineBerberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy. |
| Placebo group | Placebo comparator | Drug: PlaceboAccept placebo(300 mg/tid)+SGAs monotherapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals who age 18 to 60 years diagnose schizophrenia according the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID).
- The patients have illness for less than 5 years and have stable dose of the current antipsychotic drug for at least one month.
- Well established compliance with inpatient treatment per treating clinician's judgment. On baseline, at least 60 for Positive and Negative Syndrome Scale (PANSS) total score.
- Able to complete the cognitive assessment battery Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.
Key exclusion criteria (4 listed)
- Individuals who refuse to provide informed consent.
- Currently substance abuse or psychiatrically unstable per treating clinician's judgment.
- One with significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases also not suitable for this trial.
- 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 pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BerberineAlso: Huang Liansu, Rhizoma coptidisBerberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy. | Drug | Berberine group |
| PlaceboAccept placebo(300 mg/tid)+SGAs monotherapy. | Drug | Placebo group |
Primary outcome
The change of glucose
Time frame: Change from Baseline Glucose at 12 weeks
The change of insulin
Time frame: Change from Baseline insulin at 12 weeks
The change of HbA1c
Time frame: Change from Baseline HbA1c at 12 weeks
The change of lipid profile
Time frame: Change from Baseline lipid profile at 12 weeks
The change of CRP
Time frame: Change from Baseline CRP at 12 weeks
The change of IL-1β
Time frame: Change from Baseline IL-1β at 12 weeks
The change of IL-6
Time frame: Change from Baseline IL-6 at 12 weeks
The change of TNF-α
Time frame: Change from Baseline TNF-α at 12 weeks
The change of Cognitive function assessed with The MATRICS Consensus Cognitive Battery (MCCB)
Time frame: Change from Baseline Cognitive function at 12 weeks
The MATRICS Consensus Cognitive Battery (MCCB) for Cognitive function
2 secondary outcomes
The change of clinical symptoms assessed with The Positive and Negative Syndrome Scale
Time frame: Change from Baseline clinical symptoms at 12 weeks
Adverse event
Time frame: At 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berberine in people with Schizophrenia, run by Tianjin Anding Hospital at 1 site in China.
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 4 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 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The change of glucose (time frame: Change from Baseline Glucose at 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2018.