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 stagePossible USA, Canada Scandinavian countries three arms RecommendedEuropean countries ImpossibleGermany, Japan randomized withdrawal study (relapse/recurrence) NecessaryEurope RecommendedJapan

Antidepressants (2) Bridging study － possible in Japan － ・ same protocol ・ same subject group ・ same drug therapy assessment of diagnostic criteria DSM- Ⅳ ICD-10 assessment of efficacy criteria CGI HAM-D MADRS Training for inter-rater reliability

Antidepressants (3) Phase Ⅰ study Phase Ⅱ a study Phase Ⅱ b study Phase Ⅲ study two comparative trials TCA trazodon → SSRI SNRI Long-term study

Antipsychotics (1) Use of placebo PossibleUSA, Canada Impossible Europe Japan Schizophrenia - Progressive and irreversible the earlier, the better

Antipsychotics (2) Bridging study (1)-difficult in Japan- assessment of diagnostic criteria DSM- Ⅳ ICD-10paranoid disorganized (hebephrenic) schizo - affective assessment of efficacy criteria CGI BPRS PANSS assessment of adverse events EPSDIEPS Simpson – Angus AkathisiaBarnes Training for inter-rater reliability

Antipsychotics (3) Bridging study (2) protocol subject group acute/acute exacerbationUSA chronicJapan method for drug therapy mono therapyUSA combination therapyJapan

Antipsychotics (4) Phase Ⅰ study Phase Ⅱ a study Phase Ⅱ b study Phase Ⅲ study two comparative trials in Japan haloperidol mosapramine → atypicals (risperidone) Long-term study