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How does difference in medical practice in Japan and the rest of the world effect drug development?
_ in the field of antidepressants _and antipsychotics
Mitsukuni Murasaki(Institute of CNS Pharmacology)
Antidepressants (1)
Use of placebo
in any stage PossibleUSA, CanadaScandinavian countries
three armsRecommended
European countries
Impossible Germany, Japan
randomized withdrawal study (relapse/recurrence)
Necessary Europe
Recommended
Japan
Antidepressants (2)
Bridging study - possible in Japan -・ same protocol・ same subject group・ same drug therapy
assessment of diagnostic criteriaDSM-ⅣICD-10
assessment of efficacy criteriaCGIHAM-DMADRS
Training for inter-rater reliability
Antidepressants (3)
Phase ⅠstudyPhase Ⅱa studyPhase Ⅱb studyPhase Ⅲ study two comparative trials
TCA trazodon → SSRI SNRI
Long-term study
Antipsychotics (1)
Use of placebo
Possible USA, Canada
ImpossibleEuropeJapan
Schizophrenia - Progressive and irreversible the earlier, the better
Antipsychotics (2)
Bridging study (1) -difficult in Japan-assessment of diagnostic criteria
DSM-ⅣICD-10 paranoid
disorganized (hebephrenic)
schizo - affectiveassessment of efficacy criteria
CGIBPRSPANSS
assessment of adverse eventsEPS DIEPS
Simpson – AngusAkathisia Barnes
Training for inter-rater reliability
Antipsychotics (3)
Bridging study (2)
protocol
subject groupacute/acute exacerbation USAchronic Japan
method for drug therapymono therapy USAcombination therapy
Japan
Antipsychotics (4)
Phase ⅠstudyPhase Ⅱa studyPhase Ⅱb studyPhase Ⅲ study two comparative trials in Japan
haloperidolmosapramine → atypicals
(risperidone)Long-term study