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Berberine

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment113
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02983188Berberine as Adjuvant Treatment for Schizophrenia PatientsPHASE2 COMPLETED 113Apr 25, 2018Jan 4, 2021Jan 22, 20211 Hong Kong
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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 — 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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