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Berberine

Phase 2

Schizophrenia | Small molecule | Metabolic |Castle Biosciences, Inc.|Last Updated: Jan 22, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment113

FDA Designations

No designations recorded

Clinical trial landscape

Berberine · 1 trial · 3 indications

Phase 2 1
NCT02983188Berberine as Adjuvant Treatment for Schizophrenia PatientsSchizophrenia
COMPLETED113 Analytics
PHASE2COMPLETED
Berberine as Adjuvant Treatment for Schizophrenia Patients
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Changes in net weight gain
Baseline, 3 week, 6 week, 9 week, 12 week

Assessments will be conducted at baseline and once every three weeks thereafter.

Secondary Endpoints

Changes in body mass index (BMI)
Baseline, 3 week, 6 week, 9 week, 12 week
Changes in waist circumference (WC)
Baseline, 3 week, 6 week, 9 week, 12 week
Changes in blood pressure
Baseline, 6 week, 12 week
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BerberineACTIVE_COMPARATORPatients will receive berberine pills in additional to current atypical antipsychotic agents
PlaceboPLACEBO_COMPARATORPatients will receive placebos pills in additional to current atypical antipsychotic agents

Interventions

NameTypeDescription
BerberineDRUGBerberine tablets, 0.3g every time, two times daily
PlacebosDRUGPlacebo tablets, 0.3g every time, two times daily
Antipsychotic AgentsDRUGAntipsychotic agents prescribed at the discretion of the patients' psychiatrists with respect to patients' conditions. Concomitant use of other psychotropic drugs, including antidepressants, anxiolytics, and mood stabilizers for mood disorders, benzodiazepines and non-benzodiazepines for insomnia, and anticholinergics for extrapyramidal symptoms, was allowed as usual. For those who were under anti-hyperlipidemic, antihypertensive and anti-diabetic treatment, they were allowed to continue their current medications throughout the study.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * a primary diagnosis of SSD, including schizophrenia, schizoaffective disorder, schizophreniform disorder, and psychotic disorder not otherwise specified according to the Classification of Mental and Behavior Disorders (10th version); * have been under atypical antipsychotic tr...

Countries:Hong Kong
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Frequently asked questions about Berberine

What is Berberine used for in schizophrenia?

Berberine is an investigational small molecule being studied as an adjuvant treatment for schizophrenia. In a Phase 2 clinical trial, it was evaluated in patients with schizophrenia, schizophrenia spectrum and other psychotic disorders, and metabolic syndrome. The study has been completed.

What does Berberine target?

Berberine is a small molecule being developed by Castle Biosciences, Inc. for use in schizophrenia. The specific molecular target of berberine is not disclosed in the available information. It is being studied as an adjunctive treatment in patients with schizophrenia and metabolic syndrome.

Who makes Berberine?

Berberine is being developed by Castle Biosciences, Inc., a company traded on the stock exchange under the ticker symbol CSTL. The company is conducting clinical research on berberine as a potential treatment for schizophrenia.

What phase is Berberine in?

Berberine is in Phase 2 clinical development. A Phase 2 clinical trial has been completed, evaluating berberine as an adjuvant treatment for schizophrenia patients. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Berberine in?

Berberine has one completed clinical trial registered under NCT02983188, titled 'Berberine as Adjuvant Treatment for Schizophrenia Patients'. This Phase 2 study enrolled 113 participants in Hong Kong and was a randomized, double-blind, placebo-controlled trial.

Is Berberine the same as other names?

Berberine is a naturally occurring compound found in several plants, including goldenseal, barberry, and tree turmeric. It is also known by the chemical name berberine hydrochloride. In the context of this clinical trial, it is being studied as a supplement for schizophrenia treatment.