1. 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)

2. 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

3. 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

4. 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

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

6. 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

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

8. 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