ᚌჭĈૉФͶೃॿߺᘰႠডॽॾ˞тБॾૉڟЫʹ̀Ă
̾̅ᅨ͑ցوӪᆏឮᗾڐૉڱ˞ьମ؈ᏞჄьମїߏ
وӪႠডॾᗾڐڟͶೃॿߺᘰႠডॽॾڟтБॾૉĂФᅨ͑ЫʹڟࡳᏎؒĄOTSUKA ABILIFY (aripiprazole)ծΐय࢟վٽᑛͶೃॿߺᘰڟႠডॽॾĄ
[Վᚌჭַ٧๎ձ
(5.1)]Ą
഻ೈࠂՀΰӪᆏឮዘ̀േăۧ̍Б̅БᄆЙʡ͎୪ьମ؈Ꮮ̅ьମїߏڟࡳᏎĄ
ղࠂՀծΐΰဇ24ຑ̾ʰૉڱպӪᆏឮዘढ͎୪ьମ؈ᏞჄьମїߏڟࡳᏎ̀
ćϵ65ຑ(Ҥ)̾ʰڟૉڱ˛ĂպӪᆏឮዘढڟࡳᏎФѳڟ୪ණ
[Վᚌჭַ٧๎ձ
(5.3)]
Ąဇז֧ӪᆏឮዘٽᑛڟؚФБᚭᅹڟૉڱĂᙒઝណဆސҏФᒝӗےᆉಌ˽ă͎୪ьମ
؈ᏞჄьମїߏ˞ႧݨڑٷĄᐖҙڣࣜᚴჄັ᛫ڱᙒઝណဆ̾̅Ⴤ̟ᖂࣱ۳ݻᒒᗮĄ
[Վᚌჭַ٧๎ձ(5.3)]
Ą2!ኌᐖॿ
ԙΡڷߧЍԑ(13Ս17ྑ)ޟࡦឈѶ፡Ȅ
ԙΡڷڋ็(10Ս17ྑ)ޟᚖྃܒϞនีհЅӫีհȂџᐿٺҢܖୈ࣏Ꭴᢄܖ ValproateޟሄօݽᕛȄ
ΙᚖྃܒᆰࡻݽᕛϞᎤᢄܖvalproateޟሄօݽᕛȄ १ϞሄօݽᕛȄ
ڋ็(6Ս17ྑ)ޟՌഖܒբᓍϞࡨនܾࡥȄ
ׂ࿅ЪȄ
3!ٲු
2.1 ݦᚈͶቡॿ
ЙʡOTSUKA ABILIFYޟ࡚ដଔۖᏘ໔ᇄҬᏘ໔࣏ؐР10ܖ15యպȂΙРΙԩȂϚՃኌ
ॵӰશȄငفಛܒຟեࡣᡗҰOTSUKA ABILIFYؐРᏘ໔ӵ10~30యպጒ൜ϱԤᕛਝޟȄ ณՄȂଽܻؐР10~15యպޟҢ໔ȂٮؠԤᡗҰюԤၶٹޟਝݎȄਝႀڗᛧۡޑᄘሯौ2
໊Ȃ࢈ӵ݈Ґႀ2໊ȂϚᔖ၎ቨёᏘ໔[َᖝחंـ(14.1)]Ȅ
ᆰࡻݽᕛ-ᆰࡻݽᕛϞᕛਝϐӵΙএବᄇϐင݈ҢڏтתᆠડސέএТܖδϞᛧ
ۡޟࡦឈѶ፡ޟၐᡛϛᕕுᜌᄂȄԊ௶тঈୄҢӑࠉޟސࡣȂᓍᐠϷՍؐР݈Ң OTSUKA ABILIFY 15యպܖԊኑᏘȇᢎᄆтঈήپޟඈีޑݷ[َᖝחंـ(14.1)]
Ȅᔖ၎ۡຟե֏ሯौ៉ᆰࡻݽᕛȄ
ۧ̍Б
OTSUKA ABILIFYޟ࡚ដҬᏘ໔࣏10యպ/РȄӵaripiprazoleޟंـϛෆବᄇ13Ս17ྑޟߧ ЍԑࡦឈѶ፡ޱٺҢؐР10యպᇄ30యպޟᏘ໔ȄٲܚٺҢϞᒻᏘޟଔۖؐРᏘ ໔࣏2యպȂٮܻ2Јࡣ፡ᐌ࣏5యպȂӔܻѪѴ2ЈϞࡣ፡ᐌՍ10యպޟҬᏘ໔Ȅࡣ៉ࠌᔖ оؐԩቨё5యպޟПԒඪଽᏘ໔Ȅ30యպ/РޟᏘ໔ٮҐ֕౪юၶ10యպ/РϞᏘ໔ٹޟᕛ ਝȄٺҢOTSUKA ABILIFYਢٮϚՃኌॵӰશ[َᖝחंـ(14.1)]Ȅޱᔖۡڧ१
ཱིຟեȂоጂᇯᆰࡻݽᕛޟ҆ौܒȄ Υ֏͂ӪႠডॾᗾڐಲ OTSUKA ABILIFY
ᜰܻӑࠉٺҢڏтתᆠડސݽᕛޟࡦឈѶ፡ᙽՍ݈ҢOTSUKA ABILIFYܖځ݈
ڏтתᆠડސޟПԒȂҬࠉۦҐԝڗԤفಛᐌ౩ޟၥਟپ݂ጂӴᇳ݂Ȅᄇ࢚ٲࡦឈѶ
፡پᇳȂҳ։ୄҢӑࠉٺҢޟתᆠડސџоڧȂᄇܻڏтپᇳȂംᅚୄ
ޟПԒȂџശᎌ࿋ޟȄӵܚԤਰٽϛȂ१᠒݈ҢϚӣᆠડސޟਢȂᔖ၎ᅾ໔
ՍശωȄ
2.2 ᖖؒॽૉ
ᚓॿവѰ̅ϫܮവѰ˞ݨؒٽᑛ
ԙΡȈOTSUKA ABILIFYΙސᕛݲޟ࡚ដଔۖᏘ໔࣏15యպ/РȂΙРΙԩȂՄୈ࣏Ꭴᢄ ܖvalproateޟሄօݽᕛޟ࡚ដଔۖᏘ໔࣏10-15యպ/РȂΙРΙԩȂϚՃኌॵӰશȄ࡚ដ ޟҬᏘ໔࣏15యպ/РȂџୈ࣏Ιސݽᕛܖୈ࣏ᎤᢄܖvalproateޟሄօݽᕛȄᏘ໔џٷ ᖝחІᔖඪଽՍ30యպ/РȄ30యպ/РоΰϞᏘ໔ޟԊӒܒۦҐӵᖝחၐᡛຟեႆ[َᖝח
ंـ(14.2)]Ȅ
ڋ็ȈOTSUKA ABILIFYୈ࣏10Ս17ྑڋ็Ιސݽᕛޟ࡚ដଔۖᏘ໔࣏2యպ/РȂٮ
ܻ2Јࡣ፡ᐌ࣏5యպ/РȂӔܻѪѴ2ЈϞࡣ፡ᐌՍ10యպ/РޟҬᏘ໔ȄOTSUKA ABILIFY
ୈ࣏Ꭴᢄܖvalproateޟሄօݽᕛޟ࡚ដᏘ໔ᇄΙސݽᕛࣺӣȄԃݎԤሯौޟၗȂࠌࡣ៉
ᔖоؐԩቨё5యպޟПԒඪଽᏘ໔ȄٺҢOTSUKA ABILIFYਢȂٮϚՃኌॵӰશ[َ
ᖝחंـ(14.2)]Ȅ
2.3 ࡧឮॿ˞ᄄ҅ٽᑛ
ЙʡٺҢOTSUKA ABILIFYୈ࣏ϐٺҢתᏘݽᕛϞޱޟሄօݽᕛҢਢȂ࡚ដଔۖᏘ໔࣏
2యպ/РՍ5యպ/РȄ࡚ដᏘ໔ጒ൜2యպ/РՍ15యպ/РȄᔖоؐԩϚ຺ႆ5యպ/РޟПԒ
ം؏፡ᐌᏘ໔ȂиႤϚџЍܻ1໊[َᖝחंـ(14.3)]Ȅޱᔖۡڧ१ཱིຟեȂоጂ ᇯᆰࡻݽᕛޟ҆ौܒȄ
2.4ьఖؒॽૉѢᏍ˞ݨᚓؾݥ
േॾૉ(6~17ຑ)
ڋ็ՌഖܒբᓍϞࡨនܾࡥϞ࡚ដᏘ໔ጒ൜࣏5యպ/РՍ15యպ/РȄ
OTSUKA ABILIFYޟଔۖᏘ໔࣏ؐРᏘ໔2యպȂԃݎሯौȂؐРᏘ໔ቨёՍ5యպȂӔ ቨёՍ10యպ/Рܖ15యպ/РȄᔖоؐԩϚ຺ႆ5యպ/РޟПԒം؏፡ᐌᏘ໔ȂиႤϚџЍ
ܻ1໊[َᖝחंـ(14.4)]Ȅޱᔖۡڧ१ཱིຟեȂоጂᇯᆰࡻݽᕛޟ҆ौܒȄ
2.5 ӂ̪ॿ
േॾૉ(6~18ຑ)
ׂ࿅ЪϞ࡚ដᏘ໔ጒ൜࣏5యպ/РՍ20యպ/РȄ
ᄇܻᡝ१ωܻ50ϴОޟޱȂଔۖᏘ໔࣏ؐР2యպȂٮӵڍЈࡣႀڗҬᏘ໔5యպ/РȄӵ ܪଢ଼ (tics)Ґᕕ౩དڙޟޱȂџቨёᏘ໔Ս10యպ/РȄᔖоؐԩϚ຺ႆ5యպ/РޟПԒം
؏፡ᐌᏘ໔ȂиႤϚџЍܻ1໊Ȅ
ᄇܻᡝ१σܻ50ϴОޟޱȂଔۖᏘ໔࣏2యպ/РȂٺҢ2ЈȂϞࡣቨёᏘ໔Ս5యպ/РȂٺ Ң5ЈȂҬᏘ໔࣏ӵ8Јਢႀ10యպ/РȄӵܪଢ଼(tics)Ґᕕ౩དڙޟޱȂџቨёᏘ໔Ս 20యպ/РȄᔖоؐԩϚ຺ႆ5యպ/РޟПԒം؏፡ᐌᏘ໔ȂиႤϚџЍܻ1໊[َᖝחं
ـ(14.5)]Ȅ
2.6 ዘුቡጌ
ᄇϐޣ࣏CYP2D6Ϛيфᗂ(poor metabolizers)ޱᇄӣਢځ݈CYP3A4ڙᏘܖCYP2D6
ڙᏘܖਝCYP3A4ᇶᏲᏘޟޱ࡚ដ፡ᐌᏘ໔(ߒ1)ȄӫځݽᕛޟސୄҢࡣȂOTSUKA ABILIFYޟᏘ໔ᔖ፡ᐌՍғலᏘ໔Ȅ࿋ਝCYP3A4ᇶᏲᏘୄҢࡣȂᔖӵ1~2໊ϱOTSUKA ABILIFYޟᏘ໔६࣏ғலᏘ໔Ȅ࿋҆ӣਢٺҢaripiprazoleᇄڎਝȃϛਝܖ৵ਝޟCYP3A4 ڷCYP2D6ڙᏘਢ(ԃ:ਝޟCYP3A4ڙᏘڷϛਝޟCYP2D6ڙᏘȂܖϛਝޟCYP3A4
ڙᏘڷϛਝޟCYP2D6ڙᏘ)ȂaripiprazoleޟᏘ໔ᔖӑ࣏ΙૡᏘ໔ޟѲϷϞΙ(25%)ȂӔਲ਼ ᐃᖝחІᔖം؏፡ᐌᏘ໔Ȅ
ے1:ဇػCYP2D6˚Պ̈́ᓂ(poor metabolizers)ૉڱჄϣढցوCYP2D6ӻ֙ዘؖCYP3A4ӻ֙
ዘ̅/ؖCYP3A4ჶዲዘڟૉڱպOTSUKA ABILIFY˞ዘුቡጌݚᚊ
ᆇᛪϰ˅ OTSUKA ABILIFYዘුቡጌ
CYP2D6Ϛيфᗂޱ ϠΙૡᏘ໔ޟΠϷϞΙ
CYP2D6Ϛيфᗂޱځ݈ਝCYP3A4ڙᏘ
(ԃȈitraconazole, clarithromycin) ϠΙૡᏘ໔ޟѲϷϞΙ
ਝCYP2D6ڙᏘ(ԃȈTXLQLGLQHÀXR[HWLQH
SDUR[HWLQH ܖCYP3A4ڙᏘ(ԃȈitraconazole, clarithromycin)
ϠΙૡᏘ໔ޟΠϷϞΙ
ਝCYP2D6ڙᏘЅCYP3A4ڙᏘ ϠΙૡᏘ໔ޟѲϷϞΙ
ਝCYP3A4ᇶᏲᏘ(ԃ: carbamazepine, rifampin) Ιڗڍ໊ϱቨ࣏ΙૡᏘ໔Ϟڍॻ ٺҢOTSUKA ABILIFYհ࣏१ሄօݽᕛਢȂOTSUKA ABILIFYᏘ໔ԃҢݲҢ໔(2.3)ܚ ҰȂϚሯ፡ᐌᏘ໔Ȅ
4!ዘܮჄዘුि
OTSUKA ABILIFY® (aripiprazole)ᒻᏘَߒ2Ȅ ے2: OTSUKA ABILIFY® (aripiprazole) Ꮋዘ
Ꮋዘዘු ᎻዘĂᖟѓ/Ӝڑ Ꮋዘ༴Ğ֓ϟğ
2 ଯѺ ᆦՓȂߝПᐛ༫ל "A-006"Ѕ "2"
5 ଯѺ ᙢՓȂߝПᐛ༫ל "A-007"Ѕ "5"
10 ଯѺ औՓȂߝПᐛ༫ל "A-008"Ѕ "10"
15 ଯѺ ༁ՓȂ༫ל "A-009"Ѕ "15"
20 ଯѺ ҩՓȂ༫ל "A-010"Ѕ "20"
30 ଯѺ औՓȂ༫ל "A-011"Ѕ "30"
5!Ӡॿ
ᄇOTSUKA ABILIFYෆႆఃޱ࣏ҏࠢϞנȄІᔖጒ൜ѓ֤ཫᝨ/⼧ബՍႆఃܒІᔖ[
َϚيІᔖ(6.2)]Ȅ
6!ᚌჭַ٧๎ձ
5.1 ػૉФͶೃॿߺᘰႠডॽॾڟтБॾૉڟЫʹ̀
Ыʹ̀
وӪႠডॾᗾڐڟͶೃॿߺᘰႠডॽॾڟтБॾૉ̨وЊᆑዘڱĂФᅨ͑ЫʹڟࡳᏎ
ؒĄOTSUKA ABILIFY (aripiprazole)ծΐय࢟վٽᑛͶೃॿߺᘰڟႠডॽॾ[Վฃऱᚌ ჭ]Ą
ցФۡ৭ॕॿ˞ႠডॽॾтБॾૉڟЊϒؒߺᘰ༄
ӵέএବᄇځԤߡ૭ᓶϞᆠડՂԑ(n=938ȇҁ֯ԑឭȈ82.4ྑȇԑឭጒ൜Ȉ56- 99ྑ)ܚ໌ޟ10໊ԊኑᏘᄇྱၐᡛϛȂϚيІᔖൢีҡиOTSUKA ABILIFYಢϞี
ҡՍЍ࣏ԊኑᏘಢϞڍॻޟϚيٱӇѓࢂ݄ᆃ[ԊኑᏘಢ2%ȂOTSUKA ABILIFYಢ5%]ȃ
༞ᆃ(ѓࢂᚊᓗ)[ԊኑᏘಢ3%ȂOTSUKA ABILIFYಢ8%]ȃѶ(кौ࣏Ѷ)[ԊኑᏘಢ1%
ȂOTSUKA ABILIFYಢ5%]ȃႆ࡙ࢺల[ԊኑᏘಢ0%ȂOTSUKA ABILIFYಢ4%]ȃоЅᓞཷҬ ઌ[ԊኑᏘಢ1%ȂOTSUKA ABILIFYಢ4%]Ȅ
ٺҢOTSUKA ABILIFYݽᕛځԤѶසϞᆠડޱޟԊӒܒᇄᕛਝҬࠉۦҐጂҳȄП ᚂৱԃݎᒵᐅٺҢOTSUKA ABILIFYݽᕛޱȂौຟե֏ю౪֍ᚼ֨ᜲܖႆ࡙༞ᆃޟ
˃ะЊγಈ ® Ꮋ
OTSUKA ABILIFY ® (aripiprazole) Tablets
2 యպ ፏഋᒯԅ027033ဴ
5 యպ ፏဍᒯԅ024046ဴ
10 యպ ፏဍᒯԅ024047ဴ
15 యպ ፏဍᒯԅ024048ဴ
20 యպ ፏဍᒯԅ024049ဴ
30 యպ ፏဍᒯԅ024050ဴ
ҏҥᚂৱПٺҢ
౪ຫȂӰ࣏ٲ౪ຫ࡞ৠܾᏲमཎѴ༌ܖা༧[һَ༃ឌᇭ]Ȅ
5.2 ༞і႓˚ՊձχĂ͓ނ˛ࡳ
ӵѶසࣺᜰޟᆠડޟԊኑᏘᄇྱޟᖝחၐᡛϛ(ڍএᖝחၐᡛ௴ኆܒᏘ໔ȂΙএᖝחၐ ᡛ௴ھۡᏘ໔)Ȃ݈Ңaripiprazoleޟ(ҁ֯ԑឭȈ84ྑȇጒ൜Ȉ78-88ྑ) ԤသՖᆓϚيٱӇ (ٽԃȈϛॳȃਢܒીՖีհ)ѓࢂԫιȂีҡቨёޟלȄӵھۡᏘ໔ޟၐᡛ၇Ȃ݈Ң aripiprazoleޟသՖᆓϚيٱӇีҡᇄᏘ໔ІᔖԤಛॎΰᡗޟࣺᜰܒȄݧཎȈAripiprazole ҐೝਯটҢپݽᕛѶසࣺᜰޟᆠડ[َ༃ឌᇭ]Ȅ
5.3 േăۧ̍БჄБᄆЙʡ˞ьମ؈ᏞჄьମїߏ
१ޱ(ѓࢂԙΡᇄڋ็)ȂϚ፣тঈ֏ٺҢתސݽᕛȂџོငᐣඌϽ Ѕ(ܖ)ю౪ՌమϞ܈ᓞᇄ࣏(Ռమཎყ)ܖ࣏லᡐޟ୰ᚠȂиԪॳᓎџོΙޢࡻ៉ڗ
݂ᡗጥ၌࣏ХȄՌమΝЅ࢚ٲᆠડޟϐޣॳᓎϞΙȂՄиٲҏ٘൷
ശԤΨޟՌమႱกࡾȄϚႆȂߝδоپΙޢԤΙএኌȂһ։ӵߑݽᕛȂת
Ꮨџོᇶٺ࢚ٲޱีҡඌϽޟ౪ຫЅю౪ՌమཎყȄବᄇԊኑᏘᄇྱܒת
Ꮨ(ѓࢂᒵᐅܒՖ఼શӱԝڙᏘ(SSRIs)ЅڏѺސ)ၐᡛܚ໌ޟᆣӫϷݙᡗҰȂٲ
ސོቨёԤ१ЅڏѺᆠડϞڋ็ȃߧЍԑЅԑሆԙΡ(18-24ྑ)ю౪ՌమϞ܈ᓞᇄ
࣏(Ռమཎყ)ޟॳᓎȄंـٮҐᡗҰᄇ24ྑоΰޟԙΡٺҢתᏘਢю౪Ռమཎყޟ ॳᓎོၶٺҢԊኑᏘޱЀଽȇӵ65ྑ(֤)оΰޟԙΡϛȂٺҢתᏘਢޟॳᓎԤၶٺҢԊኑ Ꮨޱ६ճޟ౪ຫȄ
оବᄇԤ१ȃफ़ܖڏѺᆠડϞڋ็ᇄߧЍԑܚ໌ϞԊኑᏘᄇྱၐᡛ࣏Ҭ
ޟᆣӫϷݙӓొᇐ24এၐᡛȃ9ᆍתސȃоЅ຺ႆ4400ӪоΰޟޱȄоବᄇ
Ԥ१ܖڏѺᆠડϞԙΡܚ໌ϞԊኑᏘᄇྱၐᡛ࣏ҬޟᆣӫϷݙȂӓొᇐ295
ၐᡛ(ϛ՝ၐᡛ࣏2এТ)ȃ11ᆍתސȃоЅ຺ႆ77,000ӪоΰޟޱȄᗶณӨ ᆍސӵю౪ՌమཎყޟॳᓎП७Ԥ݂ᡗޟ৯ȂծӵඁнܚԤޟंـސϛȂၶԑሆϞ
ޱޟॳᓎԤЀଽޟ༊өȄϚӣᎌᔖϛޟю౪Ռమཎყޟ๘ᄇॳᓎζԤ৯Ȃٮо१
ޱϛޟีҡശଽȄϚႆȂӨԑឭቹЅӨᆍᎌᔖϛޟॳᓎ৯(ސڷԊኑᏘࣺШၶ)
֕౪ࣺᄇᛧۡޟޑᄘȄٲॳᓎ৯(ސ-ԊኑᏘ৯Ȃؐ1000ӪݽᕛޱϛޟՌమཎყ
ٽኵ)ԃߒ3ܚҰȄ ے3Ĉ
Бᚭሒ(ຑ) ᗾڐ-Њᆑዘ࣯୴Ă Ԑ1000Ϫٽᑛૉڱ˛ڟьମ๎ॾսᆵ
̨Њᆑዘᅨ͑
<18 ӻю14ٽ
18-24 ӻю5ٽ
̨Њᆑዘ̍
25-64 Ѝ1ٽ
Ѝ6ٽ
ӵܚԤޟڋ็ၐᡛϛࣱҐีҡՌమٱӇȄӵԙΡၐᡛϛᗶԤՌమٽȂծٽኵٮϚٗоୈ
юӈդᜰܻސᄇՌమϞኇП७ޟ๖፣Ȅ
ҬࠉٮϚጂޣю౪Ռమཎყޟॳᓎ֏ོ۽ժՍၶߝޟٺҢ(һ։຺ႆኵএТ)ȂϚႆȂӵ ବᄇԙΡޱܚ໌ޟԊኑᏘᄇྱޟᆰࡻݽᕛၐᡛϛԤ݂ጂޟᜌᐃᡗҰȂٺҢת
Ꮨџ۽ጥඈีޟਢȄ
ဇؚФպӪᆏឮዘٽᑛψѤኌᐖॿڟॾૉᐖїኌ໋ڟၿගĂծᙒઝណဆސҏФᒝӗے ୪ಌ˽ă͎୪ьମ๎ă̾̅їߏ୴લӽᝐڟ୪ණĂ५ѿސϵశۑಁ̢ڟᗾڐٽᑛೈĂ
ؖސӽᝐዘුڟढĂ˚ባސᅨ͑ዘුؖѳዘුĄ
ӵٺҢתᏘݽᕛ१ЅڏѺᎌᔖ(ѓࢂᆠડᇄߨᆠડ)ޟԙΡᇄڋ็ޱ ϛȂෆԤีҡήӖޑޟൢ֙Ȉฐኌȃᐭଢ଼ȃৼབྷีհȃѶȃܾࡥȃኳཎȃᔞ࣏ȃፐ ଢ଼࣏ȃᓗֲϚ(ᆠડၼଢ଼ܒྮនϚԊ)ȃሆشនȃоЅشនȄᗶณю౪Ԫޑᇄ
ඌϽЅ(ܖ)ю౪Ռమፐଢ଼ޟӰݎᜰ߽ۦҐጂҳȂծȂᗙԤԪޑџю౪Ռమཎყ ϞࠉӐޟኌȄ
ᄇϚᘞඌϽޟޱȂܖएณю౪Ռమཎყܖีҡџ࣏ඌϽܖю౪ՌమཎყϞ ࠉӐޟޑޟޱȂ੫տԃݎٲޑ࡞ᝒ१ȃีҡு࡞एณȃܖٮߨޱনپޟߒ౪
ޑਢȂᔖՃኌᡐݽᕛޟПԒȂѓࢂџौୄХԪސޟݽᕛȄ
ᐖᝥִպӪᆏឮዘٽᑛࡧឮॿؖ֏ͺኌᐖॿ)͓ނႠডॽॾჄۨႠডॽॾ*˞ૉڱڟࣜᚴჄ
ັ᛫ڱĂਜ਼Άၿගૉڱސҏ͎୪ጭăؾݥăїߏ୴લӽᝐă̾̅܉ࡘڟ֏ͺॿڑĂᓙФސ ҏ͎୪ьମڟ๎Ăծਜ਼Άγ҉ઠЪᘸॿڑϩશັᛖʡࢷౢĄႍၿගᐖ͓ނΥࣜᚴჄ
ັ᛫ڱԐ̈їណဆĄ࣏६ճҢႆ໔ޟॳᓎȂOTSUKA ABILIFYޟПᔖ௴Ңஊႀڗي ԁڙਝݎޟശЍޟᒻᏘ໔Ȅ
።ᐮૉڱސҏ፯ૉᖖؒॽૉĈ१ีհ࡞џᚖྃܒޟߑߒȄΙૡᇯ࣏(ᗶณ ۦҐӵᄇྱၐᡛϛᕕுጂҳ)ȂᄇԤᑯᚖྃܒϞॳᓎޟޱȂᐿٺҢתᏘݽᕛ
ᆍีհџོЀଽएณีҡӫีհ/នีհޟџܒȄҬࠉٮϚጂޣΰक़ӈդޑ֏
࣏ᆍᙽᡐޟӐȄฒ፣ԃդȂӵۖٺҢתᏘݽᕛю౪ޑޟޱϞࠉȂࣱᔖӑ
໌ᎌ࿋ޟᑢᔮȂᙤоጂᇯтঈ֏ԤᑯᚖྃܒޟॳᓎȂԪᑢᔮᔖѓ֤၏ᅾޟᆠડ
ѬȂѓࢂՌమȃᚖྃܒЅޟড়ఊѬȄ
ᔖݧཎޟȂOTSUKA ABILIFYٮҐೝਯটҢܻݽᕛڋ็ޱȄ
5.4 ӪႠডॾᗾڐಌؒॿ༐(NMS)
ᇄתᆠડސȂѓࢂaripiprazoleȂᇄΙᆍџमڼޟፒӫᝩঐɯᆎ࣏ȶתᆠડސඌ ܒঐတ(NMS)ȷԤᜰȄӵaripiprazoleޟӒ౨ܒᖝחၐᡛϛȂӵ݈ҢaripiprazoleقԤีҡ ᅸխתᆠડސඌܒঐတȄתᆠડސඌܒঐတޟᖝחߒ౪࣏ีଽᐶȃՊՈቊȃ ᆠડޑݷᡐȃоЅՌкડငفಛϚᛧۡޟ౪ຫ(ཀྵܖՖᔆϚೣࠌȃЖၰႆפȃีԮȃڷЖ
ࡡல)ȄڏтޑџѓࢂԤՖ఼ϛՊሖᕥᐭ酶֤໔ΰЀȃՊ౨ೖҩ(ᐗՊྙ၌)ȃ ᇄࡨܒ૾ᆑȄ
࣏ᑯԪޑޟୈຨᘞܒຟեࣺ࿋ፒᚕȄौୈюຨᘞȂ१ौޟȂौӑ௶ଶᖝחߒ౪឴
ܻϱऋ१(ԃȈއȃӒ٘ܒཐ้้)ЅҐݽᕛܖݽᕛϚ࿋ϞᓅᡝѴ৷ঐတ(EPS)Ϟ
ٽȄڏтᠦտຨᘞਢޟ१ौՃ໔ȂѓࢂԤϛኾתᖚᢃܒࢳܒȂዥϛෂȃސዥڷনีܒϛኾ ડငفಛᡐȄ
תᆠડސඌܒঐတϞညᔖѓ֤Ȉ
1)ҳ։ୄҢתᆠડސоЅᄇ౪ࢲݽᕛߨ҆ސȇ2)ࢊоޑݽᕛٮᅿȇ3)ԃ Ԥբᓍีҡޟᝒ१୰ᚠȂٮԤ੫ۡϞݽᕛПԒޱȂ։ᔖ໌ݽᕛȄବᄇฒځีޟתᆠડ
ސඌܒঐတȂᏰࣨᗙҐԤΙमᇯӣޟ੫ۡސݽᕛПԒȄ
ԃݎӵՌתᆠડސඌܒঐတஶඈࡣȂሯौתᆠડސݽᕛȂᔖ࿋བ१ՃኌҢ
ЕଔϞঐတඈีޟџܒȄҥܻෆԤൢ֙ࡾюתᆠડސඌܒঐတޟඈีਰٽȂܚо ᔖ၎ωЖӴᅿݷȄ
5.5 ᎶവོؒҨᘲ
݈ҢתᆠડސޟȂџีҡޟΙᆍঐတ(ᒶีܒၼଢ଼֨ᜲ)ȂᏲमΙٲዖӵܒӴϚ џଛޟȂϚՌкޟȂၼଢ଼Ԥራᛤޟଢ଼հȄᗶณԪޑޟ౾ӵՂԑΡϞശଽȂ੫տԑ ߝτܒȇծȂӵתᆠડݽᕛߑۖȂζ൷ৠܾีҡԪޑޟਢȂདআᎬ౾
եॎپႱกԪঐတϞีҡȂϚџޟȄӨᆍתᆠડސЕีᒶีܒၼଢ଼֨ᜲޟџ
ܒϫณҐޣȄ
ีҡᒶีܒၼଢ଼֨ᜲޟॳᓎȂᇄ၎ঐတᡐ࣏ϚџଛϞџܒȂᐃོ߬ᓍݽᕛਢȂڷ
݈ࡣȂᡝϱתᆠડސϞᖂಣᑖ໔ቨёՄቨёȄณՄȂԪঐတζџีҡӵਢȃ ճᏘ໔Ңޟ٘ΰșᗶณᆍޑݷ࡞ЍȄ
ԃݎୄҢתᆠડސȂᗶณᒶีܒၼଢ଼֨ᜲџоഋӋܖׇӒጥ၌Ȃծᄇܻጂ࣏ۡᒶีܒၼ ଢ଼֨ᜲޟȂҬࠉؠԤϐޣޟݽᕛПԒȄณՄȂתᆠડސݽᕛҏ٘џོڙ(ܖഋϷ
ڙ)ԪঐတޟޑڷᝩঐȂՄиȂџᎍጶΟዖӵޟแȄޑڙᄇԪঐတߝแ ޟኇϫ࣏ҐޣȄ
Ѕΰक़Ճ໔ȂOTSUKA ABILIFYޟٺҢȂᔖ၎ᏑџоЍᒶีܒၼଢ଼֨ᜲޟีҡ࣏
ࠉඪȄߝޟתᆠડݽᕛᔖ၎டҢܻήक़ᄚܒȈ(1)תᆠડސᄇ၎Ԥᕛ ਝȇ(2)ᄇ၎پᇳȂؠԤڎӣ้ݽᕛਝݎȂծ༌ܒၶωޟӫᎌސџټᒵᐅȄ ᜰܻሯौߝݽᕛޟȂᔖ၎ײюџႀڗᡱΡᅖཎޟݽᕛਝݎϞശωᏘ໔ڷശݽᕛਢ แȄ៉ݽᕛޟሯؑᔖ࿋ೝۡຟեȄ
ԃݎ݈ҢOTSUKA ABILIFYޟ٘ΰю౪ᒶีܒၼଢ଼֨ᜲޟޑڷᝩঐȂᔖՃኌୄȄณ ՄȂ࢚ٲȂ։ٺӵีҡԪޟלήȂϫሯौ៉݈ҢOTSUKA ABILIFYȄ
5.6 ఙ̈́ᓂᝐ˽
ߨڐתᆠડސϐޣᇄཱིങфᗂޟᡐϽԤᜰȂٲᡐϽѓࢂՖᑥႆଽ/ᑥȂՖ્
லЅᡝ१ቨёȄߨڐתᆠડސࣱོഅԙфᗂП७ޟኇȂՄؐএސԤڏএտޟॳᓎ
྅ݷȄ
і፥྆ॿ/፥Ӎॾ
ڧߨڐתᆠડސݽᕛޟෆԤኺޟൢ֙ȂՖᑥႆଽӵΙٲਰٽᇄ⢯ሖሖϛࢳ ܖଽᅤആᔆ݄ଜܖԫιߨலԤᜰȄϐԤڧOTSUKA ABILIFYݽᕛޟԤՖᑥႆଽޟൢ
֙[َϚيІᔖ(6.1Ѕ6.2)] Ȅ
ຟեߨڐתᆠડސϞٺҢᇄՖᑥலޟࣺᜰܒߨலፒᚕޟȂџࡦឈѶ፡ӣ ਢᑯᑥޟधශӠᓎܒቨёڷΙૡΡοޟᑥีҡቨёȄЅٲϓᘙӰશȂߨڐ
תᆠડސϞٺҢᇄՖᑥႆଽࣺᜰޟϚيٱӇҐೝׇӒᕣ၌ȄณՄȂࢺᏰंـඪ ҰȈڧߨڐתᆠડސݽᕛޟོഅԙՖᑥႆଽԤᜰޟϚيІᔖԤቨёޟӠᓎ ܒȄҥܻOTSUKA ABILIFYӵٲंـ໌ਢۦҐΰѿȂϚޣၾOTSUKA ABILIFY ֏ᇄԪ ቨёޟӠᓎܒԤᜰȄᄇܻڧߨڐתᆠડސݽᕛޟีҡՖᑥႆଽԤᜰޟϚيІ ᔖޟӠᓎܒȂۦҐᆠጂեᆗȄ
ϐೝຨᘞԤᑥޟ݈ۖҢߨڐתᆠડސਢȂᔖ၎ۡᅿกՖᑥڙޟඌϽȄ
ڎԤᑥዖӵӠᓎӰυ(ٽԃȈढȃᑥড়ఊѬ)Ȃӵ݈ۖҢߨڐתᆠડ
ސਢȂᔖ၎ୈުလՖᑥޟᔮกȇӵݽᕛᔖ၎ۡᅿกՖᑥޟᡐϽȄ݈Ңߨڐתᆠડ
ސޟȂᔖ၎ᅿกՖᑥႆଽޟޑȂѓࢂቑȃӻȃೳॵڷຎ৵้Ȅڧߨڐת ᆠડސݽᕛȂषี౪ԤՖᑥႆଽޟޑȂ։ᔖ໌ުလՖᑥޟกၐȄԤٲਰٽȂ ΙҍୄҢߨڐתᆠડސȂՖᑥႆଽҳ։၌ؚȇՄԤٲᗶณϐୄҢᛄᅸޟ
ސȂϫሯौ៉תᑥސޟݽᕛȄ
ҏ࣏ࠢΙᆍߨڐתᆠડࠢȂٺҢߨڐתᆠડސོю౪ଽՖᑥЅቨёᑯိຉᑥ ञڧܒϚيܖᑥॳᓎȄЍኵᝒ१ϞਰٽԤџю౪⢯ሖՖ(ketoacidosis)ڷଽՖᑥଽᅤ ആᔆߨ⢯ᡝ ܒঐ တ(Hyperglycemic Hyperosmolar Nonketotic Coma)้ࡨᏲम݄ଜࣥՍ ԫιȄ
ܚԤڧߨڐתᆠડࠢϞȂᔖϸཎଽՖᑥޑ(ԃ:ӻॵȃቑȃӻܖฒΨ) Ȃषю౪ଽՖᑥޑਢȂᔖҳړก໔ՖᑥȄԤᑥܖᑥӠᓎӰυ(ԃȈढȃԤᑥ
ড়ఊѬ้)ϞȂҢࠉᔖᅿกՖᑥȂҢϛζᔖۡᅿกՖᑥȄᄇܻю౪݂ᡗሯौᆧࡨ ݽᕛଽՖᑥޟȂᔖՃኌୄȂԤٲୄࡣϫٺҢתᑥࠢݽᕛȄ
ᆇЫϽӫސфᗂҁᒋџོڧڗᡐՄഅԙိຉᑥۡޑݷڧཬȂӰԪџོᡱᑥࠉ
ޑᡗ౪ȂܖഅԙࢋԤޟᑥඌϽȄ Йʡ
ӵΙএѓ֤13এԊኑᏘᄇྱϞԙΡΙݽᕛၐᡛޟϷݙϛȂڏઽΣϞкौࡦឈѶ፡
ޱܖᚖྃܒϞޱȂоOTSUKA ABILIFYݽᕛϞԙΡޱڏҁ֯ުလՖᑥᡐϽ(+4.4 mg/dLȇኸ៩Јኵ(ϛ՝ኵ)Ȉ25ЈȇN=1057)ڷоԊኑᏘݽᕛϞԙΡޱҁ֯ުလՖᑥᡐϽ (+2.5 mg/dLȇኸ៩Јኵ(ϛ՝ኵ)Ȉ22ЈȇN=799)ٮฒᡗ৯Ȅߒ4ᡗҰOTSUKA ABILIFYಢ Ȟኸ៩Јኵ(ϛ՝ኵ)25ЈȟᇄԊኑᏘಢȞኸ៩Јኵ(ϛ՝ኵ)22ЈȟުလՖᑥஅጣ࣏ғலڷႀ ᖝࣨ(borderline)ϞȂีҡݽᕛࡣުလՖᑥႆଽޟШٽȄ
ے4: ̾Йʡૉڱї˞Њᆑዘဇັʙٽᑛཐ˛ڪ༜і፥˞ᝐ˽
ڪ༜і፥
ૃઅሣࢄਔڟᘸѿᝐ˽)э̍വΡʙЩ* ٽᑛѿ n/N % ғலڗଽՖᑥ OTSUKA ABILIFY 31/822 3.8 PJG/WRPJG/ Placebo 22/605 3.6 ᖝࣨڗଽՖᑥ OTSUKA ABILIFY 31/176 17.6 PJG/DQG PJG/WRPJG/ Placebo 13/142 9.2
ӵ24໊ਢоOTSUKA ABILIFYݽᕛϞԙΡޱڏҁ֯ުလՖᑥᡐϽ(+2.2 mg/dL(n=42))ڷо ԊኑᏘݽᕛϞԙΡޱҁ֯ުလՖᑥᡐϽ ( +9.6 mg/dL (n=28))ٮฒᡗ৯Ȅ
ӵ१ϞሄօݽᕛϛȂоOTSUKA ABILIFYݽᕛϞԙΡޱڏҁ֯ުလՖᑥᡐϽ(+0.7 mg/dLȂኸ៩Јኵ(ϛ՝ኵ)Ȉ42ЈȇN=241)ڷоԊኑᏘݽᕛϞԙΡޱҁ֯ުလՖᑥᡐϽ (+0.8 mg/dLȂኸ៩Јኵ(ϛ՝ኵ)Ȉ42ЈȇN=246)ٮฒᡗ৯Ȅߒ5ᡗҰ१ԙΡޱܻ
ԊኑᏘᄇྱሄօݽᕛϛުလՖᑥϞᡐϽȄ
ے5: ̾ࡧឮॿЙʡૉڱї˞Њᆑዘဇັᄄ҅ٽᑛཐ˛ڪ༜і፥˞ᝐ˽
ڪ༜і፥
ૃઅሣࢄਔڟᘸѿᝐ˽)э̍വΡʙЩ* ٽᑛѿ n/N % ғலڗଽՖᑥ OTSUKA ABILIFY 2/201 1.0 PJG/WRPJG/ Placebo 2/204 1.0 ᖝࣨڗଽՖᑥ OTSUKA ABILIFY 4/34 11.8 PJG/DQG PJG/WRPJG/ Placebo 3/37 8.1
േჄۧ̍Б
ӵΙএѓ֤2এԊኑᏘᄇྱϞࡦឈѶ፡ߧЍԑޱ(13~17ྑ)Ѕᚖྃܒڋ็ޱ(10~17
ྑ)ၐᡛޟϷݙϛȂоOTSUKA ABILIFYݽᕛϞޱڏҁ֯ުလՖᑥᡐϽ(+4.8 mg/dLȇኸ៩Ј ኵ(ϛ՝ኵ)Ȉ43ЈȇN=259)ڷоԊኑᏘݽᕛϞޱҁ֯ުလՖᑥᡐϽ(+1.7 mg/dLȇኸ៩Јኵ(
ϛ՝ኵ)Ȉ42ЈȇN=123)ٮฒᡗ৯Ȅ
ӵΙএѓ֤2এԊኑᏘᄇྱၐᡛޟϷݙϛȂઽΣՌഖܒբᓍϞࡨនܾࡥޟڋ็ЅߧЍԑ
ޱ(6~17ྑ)Ȃኸ៩Јኵ(ϛ՝ኵ)࣏56ЈȂоOTSUKA ABILIFYݽᕛϞޱڏҁ֯ުလՖᑥ ᡐϽ(-0.2 mg/dLȇN=83)ڷоԊኑᏘݽᕛϞޱҁ֯ުလՖᑥᡐϽ(-0.6 mg/dLȇN=33)ٮฒᡗ
৯Ȅ
ϷݙڍএԊኑᏘᄇྱޟׂ࿅Ъڋ็ڷߧЍԑ(6~18ྑ)ၐᡛȂኸ៩Јኵϛ՝ኵ࣏57ЈȂо OTSUKA ABILIFYݽᕛϞޱҁ֯ުလՖᑥᡐϽ(0.79 mg/dLȇN=90)ڷоԊኑᏘݽᕛϞޱ ҁ֯ުလՖᑥᡐϽ(-1.66 mg/dLȇN=58)ٮฒᡗ৯Ȅ
ߒ6࣏оOTSUKA ABILIFYܖԊኑᏘݽᕛԤࡦឈѶ፡ߧЍԑޱڷᚖྃܒڋ็ޱ (ኸ៩Јኵ(ϛ՝ኵ)࣏42~43Ј)ȂԤՌഖܒբᓍϞࡨនܾࡥޟڋ็ЅߧЍԑ(6~17ྑ) (ኸ ៩Јኵ(ϛ՝ኵ)࣏56Ј)ȂоЅԤׂ࿅Ъڋ็ޱ(6~18ྑ)(ኸ៩Јኵ࣏57Ј)ڏުလՖᑥᡐ ϽޟШٽȄ
ے6: ̾േ̅ۧ̍Бૉڱї˞Њᆑዘဇັٽᑛཐ˛ڪ༜і፥˞ᝐ˽
ૃઅሣࢄਔڟᘸѿᝐ˽
)э̍വΡʙЩ* ኌᐖॿ ٽᑛѿ n/N %
ڪ༜і፥ࢄ
ғலڗଽՖᑥ PJG/WR
mg/dL)
ࡦឈѶ፡ᇄ ᚖྃܒ
OTSUKA ABILIFY 2/236 0.8 Placebo 2/110 1.8 Ռഖܒբ
ᓍϞࡨនܾࡥ
OTSUKA ABILIFY 0/73 0 Placebo 0/32 0
ׂ࿅Ъ OTSUKA ABILIFY 3/88 3.4 Placebo 1/58 1.7
ڪ༜і፥ࢄ
ᖝࣨڗଽՖᑥ PJG/DQG
PJG/WRPJG/
ࡦឈѶ፡ᇄ ᚖྃܒ
OTSUKA ABILIFY 1/22 4.5 Placebo 0/12 0 Ռഖܒբ
ᓍϞࡨនܾࡥ
OTSUKA ABILIFY 0/9 0 Placebo 0/1 0
ׂ࿅Ъ OTSUKA ABILIFY 0/11 0 Placebo 0/4 0 ӵߧЍԑࡦឈѶ፡ᇄڋ็ᚖྃܒၐᡛϞӫځϷݙϛȂӵ12໊ਢоOTSUKA ABILIFY ݽᕛϞޱڏҁ֯ުလՖᑥᡐϽ(+2.4 mg/dL(n=81))ڷоԊኑᏘݽᕛϞޱҁ֯ުလՖᑥᡐϽ (+0.1 mg/dL(n=15))ٮฒᡗ৯Ȅ
і্୴લ
ڧߨڐתᆠડސݽᕛޟϐᢎᄆڗՖ્லȄ
оOTSUKA ABILIFYܖԊኑᏘݽᕛޟȂᢎᄆުလ/ߨުလᖂᖚھ᎕ȃުလέሖҠݶ્ȃު
လճ્࡙ೖҩ(LDLs)Ѕުလ/ߨުလଽ્࡙ೖҩ(HDLs)ҥғலڗڎᖝחཎဎϞᡐޟ
ΡኵШٽȂӵڍಢٮฒᡗ৯ȄٲϷݙኸ៩ՍЍ12໊ܖ24໊Ȃծڧ३ܻΡ ኵႆЍȄ
Йʡ
ߒ7ᡗҰкौپՌӫځࡦឈѶ፡ЅᚖྃܒϞԊኑᏘᄇྱΙݽᕛၐᡛϞԙΡޱՖ્
ᡐϽϞШٽȄѓࢂᖂᖚھ᎕(ӫځ17এၐᡛȇኸ៩Јኵ(ϛ՝ኵ)21~25Ј)ȂުလέሖҠݶ્(ӫ ځ8এၐᡛȇኸ៩Јኵ(ϛ՝ኵ)42Ј)Ȃުလճ્࡙ೖҩᖚھ᎕(ӫځ8এၐᡛȇኸ៩Јኵ(ϛ
՝ኵ)39~45ЈȄծުလճ્࡙ೖҩᖚھ᎕அጣғலϞԊኑᏘಢڏኸ៩Јኵ(ϛ՝ኵ)࣏24 ЈଶѴ)ȂоЅଽ્࡙ೖҩᖚھ᎕(ӫځ9এၐᡛȇኸ៩Јኵ(ϛ՝ኵ) 40~42Ј)Ȅ
ے7: ̾Йʡૉڱї˞Њᆑዘဇັʙٽᑛཐі্ᆵ˞ᝐ˽
ٽᑛѿ n/N %
ᒂᒚ־ን OTSUKA ABILIFY 34/1357 2.5 ғலڗଽ PJG/WRPJG/ Placebo 27/973 2.8 ڪ༜ʭᄖΠٶ্ OTSUKA ABILIFY 40/539 7.4 ғலڗଽ PJG/WRPJG/ Placebo 30/431 7.0 ڪ༜ѳઝݙ্Ωᒚ־ን OTSUKA ABILIFY 2/332 0.6 ғலڗଽ PJG/WRPJG/ Placebo 2/268 0.7
ઝݙ্Ωᒚ־ን OTSUKA ABILIFY 121/1066 11.4 ғலڗճ PJG/WR PJG/ Placebo 99/794 12.5 ӵԙΡޱΙݽᕛၐᡛϛȂӵ12໊Ѕ24໊ਢȂՖ્ᡐϽ(ғலᡐԙଽՖ્)ޟ
ΡኵШٽӵݽᕛಢڷԊኑᏘಢϛฒᡗ৯Ȉӵ12໊ਢȂᖂᖚھ᎕(ުလ/ߨުလ)࣏
1/71(1.4%) vs.3/74(4.1%)ȇުလέሖҠݶ્࣏8/62(12.9%) vs.5/37(13.5%)ȇުလճ્࡙ೖ
ҩᖚھ᎕࣏0/34(0%) vs.1/25(4.0%)ȇՄӵ24໊ਢȂᖂᖚھ᎕(ުလ/ߨުလ)࣏1/42 (2.4%) vs.3/37(8.1%)ȇުလέሖҠݶ્࣏5/34(14.7%) vs.5/20(25%)ȇުလճ્࡙ೖҩᖚھ᎕࣏
0/22(0%) vs.1/18(5.6%)Ȅ
ߒ8ᡗҰپՌڍএԊኑᏘᄇྱϞሄօݽᕛၐᡛϛޟ१ԙΡޱڏՖ્ኵᡐϽޟШٽ(ѓ
ࢂᖂᖚھ᎕(ުလ/ߨުလ)ȃުလέሖҠݶ્ȃުလճ્࡙ೖҩᖚھ᎕Ѕଽ્࡙ೖҩᖚھ
᎕ȇኸ៩Јኵ(ϛ՝ኵ)࣏42Ј)Ȅ
ے8: ̾ࡧឮॿЙʡૉڱї˞Њᆑዘဇັᄄ҅ٽᑛཐ˛і্ᆵ˞ᝐ˽
ٽᑛѿ n/N %
ᒂᒚ־ን OTSUKA ABILIFY 3/139 2.2 ғலڗଽ PJG/WRPJG/ Placebo 7/135 5.2 ڪ༜ʭᄖΠٶ্ OTSUKA ABILIFY 14/145 9.7 ғலڗଽ PJG/WRPJG/ Placebo 6/147 4.1 ڪ༜ѳઝݙ্Ωᒚ־ን OTSUKA ABILIFY 0/54 0 ғலڗଽ PJG/WRPJG/ Placebo 0/73 0
ઝݙ্Ωᒚ־ን OTSUKA ABILIFY 17/318 5.3 ғலڗճ PJG/WR PJG/ Placebo 10/286 3.5
േჄۧ̍Б
ߒ9ᡗҰࡦឈѶ፡ϞߧЍԑޱ(13~17ྑ)Ѕᚖྃܒڋ็ޱ(10~17ྑ)Ֆ્ᡐϽޟШ ٽȄᖂᖚھ᎕ڷଽ્࡙ೖҩᖚھ᎕(ӫځڍএԊኑᏘᄇྱၐᡛȂኸ៩Јኵ(ϛ՝ኵ)࣏42~43 Ј)ȇުလέሖҠݶ્ӫځڍএԊኑᏘᄇྱၐᡛȂኸ៩Јኵ(ϛ՝ኵ)࣏42~44ЈȄ
ے
9:̾ݦᚈͶቡॿַᖖؒॽૉേჄۧ̍Бૉڱї˞Њᆑዘဇັʙٽᑛཐ˛
і্ᆵ˞ᝐ˽
ٽᑛѿ n/N %
ᒂᒚ־ን OTSUKA ABILIFY 3/220 1.4 ғலڗଽ PJG/WRPJG/ Placebo 0/116 0 ڪ༜ʭᄖΠٶ্ OTSUKA ABILIFY 7/187 3.7 ғலڗଽ PJG/WRPJG/ Placebo 4/85 4.7
ઝݙ্Ωᒚ־ን OTSUKA ABILIFY 27/236 11.4 ғலڗճ PJG/WR PJG/ Placebo 22/109 20.2 ӵࡦឈѶ፡ߧЍԑޱЅᚖྃܒڋ็ޱΙݽᕛၐᡛϛȂӵ12໊Ѕ24໊ਢȂ Ֆ્ᡐϽ(ғலᡐԙଽՖ્)ޟޱΡኵШٽӵݽᕛಢڷԊኑᏘಢϛฒᡗ৯Ȉӵ
12໊ਢȂᖂᖚھ᎕(ުလ/ߨުလ)࣏0/57(0%) vs. 0/15(0%)ȇުလέሖҠݶ્࣏2/72(2.8%) vs.
1/14(7.1%)ȇՄӵ24໊ਢȂᖂᖚھ᎕(ުလ/ߨުလ)࣏0/36 (0%) vs. 0/12(0%)ȇުလέሖҠ ݶ્࣏1/47(2.1%) vs. 1/10(10%)Ȅ
ߒ10ᡗҰپՌڍএԊኑᏘᄇྱၐᡛϛՌഖܒբᓍϞࡨនܾࡥޟڋ็ޱ(6~17ྑ)ڏުလ/
ߨުလᖂᖚھ᎕ЅުလέሖҠݶ્(ኸ៩Јኵ(ϛ՝ኵ)56Ј)Ѕଽ્࡙ೖҩᖚھ᎕(ኸ៩Јኵ(
ϛ՝ኵ)55~56Ј)ϞᡐϽȄ
ے
10: ̾ьఖॿേૉڱї˞Њᆑዘဇັཐ˛і্ᆵ˞ᝐ˽
ٽᑛѿ n/N %
ᒂᒚ־ን OTSUKA ABILIFY 1/95 1.1
ғலڗଽ PJG/WRPJG/ Placebo 0/34 0 ڪ༜ʭᄖΠٶ্ OTSUKA ABILIFY 0/75 0 ғலڗଽ PJG/WRPJG/ Placebo 0/30 0
ઝݙ্Ωᒚ־ን OTSUKA ABILIFY 9/107 8.4 ғலڗճ PJG/WR PJG/ Placebo 5/49 10.2 ߒ11ᡗҰپՌڍএԊኑᏘᄇྱၐᡛϛׂ࿅ЪϞڋ็(6~18ྑ)ڏުလ/ߨުလᖂᖚھ᎕Ѕ
ުလέሖҠݶ્(ኸ៩Јኵ(ϛ՝ኵ)57Ј)Ѕଽ્࡙ೖҩᖚھ᎕(ኸ៩Јኵ(ϛ՝ኵ)57Ј)Ϟᡐ ϽȄ
ے
11: ̾ӂ̪ॿേૉڱї˞Њᆑዘဇັཐ˛і্ᆵ˞ᝐ˽
ٽᑛѿ n/N %
ᒂᒚ־ን OTSUKA ABILIFY 1/85 1.2
ғலڗଽ PJG/WRPJG/ Placebo 0/46 0 ڪ༜ʭᄖΠٶ্ OTSUKA ABILIFY 5/94 5.3 ғலڗଽ PJG/WRPJG/ Placebo 2/55 3.6
ઝݙ্Ωᒚ־ን OTSUKA ABILIFY 4/108 3.7 ғலڗճ PJG/WR PJG/ Placebo 2/67 3.0
ࡧᅨ͑
ٺҢߨڐתᆠડސོഅԙᡝ१ቨёȄ࡚ដٺҢԪސौᅿᡝ१Ȅ
Йʡ
Ϸݙѓ֤13এԊኑᏘᄇྱΙݽᕛၐᡛȂкौӫځࡦឈѶ፡ЅᚖྃܒޱȂኸ៩Ј ኵ(ϛ՝ኵ)࣏21~25ЈȄҁ֯ᡝ१ᡐϽӵOTSUKA ABILIFYಢ+0.3ϴО(N=1673)ȂԊኑᏘಢ
-0.1ϴО(N=1100)Ȅӵ24໊ਢȂஅጣޟҁ֯ᡝ१ᡐϽӵOTSUKA ABILIFYಢ-1.5ϴО (N=73) ȂԊኑᏘಢ-0.2ϴО (N=46)Ȅ
ӵתᏘځҢOTSUKA ABILIFYհ࣏ߣёݽᕛޟၐᡛϛȂޱӑڧ8໊ޟתᏘݽ ᕛȂณࡣӔёΰOTSUKA ABILIFYܖԊኑᏘ៉ݽᕛ6໊Ȅҁ֯ᡝ१ᡐϽӵOTSUKA ABILIFY ಢ+1.7ϴО(N=347)ȂՄԊኑᏘಢࠌ+0.4ϴО(N=330)Ȅ
ߒ12ᡗҰӵӨᆍϚӣޟᎌᔖήٺҢOTSUKA ABILIFYܖԊኑᏘਢȂԙΡᡝ१ቨё
ޟШٽȄ
ے
12: ϵЊᆑዘဇັཐ˛Йʡॾૉࡧᅨ͑ڟ̨ս
ኌᐖॿ ٽᑛѿ N ॾʡᆵn(%)
ࡧᅨ͑
ࡦឈѶ፡a OTSUKA ABILIFY 852 69 (8.1) Placebo 379 12 (3.2) ᚖྃܒb OTSUKA ABILIFY 719 16 (2.2) Placebo 598 16 (2.7) १ሄօݽᕛc OTSUKA ABILIFY 347 18 (5.2) Placebo 330 2 (0.6) a 4~6໊ݽᕛ. b 3໊ݽᕛ. c 6໊ݽᕛ
േჄۧ̍Б
Ϸݙѓ֤2এԊኑᏘᄇྱၐᡛϛᑯࡦឈѶ፡ϞߧЍԑ(13~17ྑ)Ѕᚖྃܒڋ็
(10~17ྑ)ޟᡝ१ᡐϽȂኸ៩Јኵ(ϛ՝ኵ)42~43ЈȄҁ֯ᡝ१ᡐϽӵOTSUKA ABILIFYಢ
࣏+1.6ϴО(N=381)ȂԊኑᏘಢ࣏+0.3ϴО(N=187)Ȅӵ24໊ਢȂஅጣޟҁ֯ᡝ१ᡐϽӵ OTSUKA ABILIFYಢ࣏+5.8ϴО(N=62)ȂԊኑᏘಢ࣏+1.4ϴО(N=13)Ȅ
оՌഖܒբᓍϞࡨនܾࡥޟڋ็(6~17ྑ)໌ޟڍএԊኑᏘᄇྱၐᡛȂኸ៩Јኵ(ϛ
՝ኵ)56ЈȂҁ֯ᡝ१ᡐϽӵOTSUKA ABILIFYಢ࣏+1.6ϴО(N=209)ȂՄԊኑᏘಢ࣏+0.4ϴ О(N=98)Ȅ
оׂ࿅Ъ(6~18ྑ)໌ޟڍএԊኑᏘᄇྱၐᡛȂኸ៩Јኵ(ϛ՝ኵ)57ЈȂҁ֯ᡝ१ ᡐϽӵOTSUKA ABILIFYಢ࣏+1.5ϴО(n=105)ȂՄԊኑᏘಢ࣏+0.4ϴОȄ
ߒ13ᡗҰӵӨᆍϚӣޟᎌᔖήٺҢOTSUKA ABILIFYܖԊኑᏘਢȂڋ็ЅߧЍԑᡝ१ ቨёޟԻϷШȄ
ے
13:ϵЊᆑዘဇັཐ˛േ̅ۧ̍Бॾૉࡧᅨ͑ Ÿ7%ڟ̨ս
ኌᐖॿ ٽᑛѿ N ॾʡᆵn(%)
ࡧᅨ͑
ࡦឈѶ፡ᇄᚖྃܒa OTSUKA ABILIFY 381 20 (5.2) Placebo 187 3 (1.6) ՌഖܒբᓍϞࡨនܾࡥb OTSUKA ABILIFY 209 55 (26.3)
Placebo 98 7 (7.1)
ׂ࿅Ъc OTSUKA ABILIFY 105 21 (20.0) Placebo 66 5 (7.6) a 4~6໊ݽᕛ. b 8໊ݽᕛ. c 8~10໊ݽᕛ.
ΙઽΣپՌڍএԊኑᏘᄇྱၐᡛϞࡦឈѶ፡ߧЍԑޱ(13~17ྑ)Ѕᚖྃܒڋ็
ޱ(10~17ྑ)ޟܹܒၐᡛϛȂ73.2% (238/325)ׇԙ26໊ޟOTSUKA ABILIFYݽᕛȄင26
໊ࡣԤ32.8%ᡝ१ቨёȂԪኵᐃҐငғலҡߝޟ፡ᐌȄငғலҡߝਮғȂցҢШၶ ԑឭȃܒտྥϽுڗZȄZᡐϽ<0.5এྥ৯(SD)ࠌຜ࣏ϚڎᖝחΰᡗཎဎȄ26໊
ࡣȂZҁ֯ᡐϽ࣏0.09এྥ৯(SD)Ȅ
ΙઽΣپՌڍএԊኑᏘᄇྱၐᡛϞՌഖܒբᓍϞࡨនܾࡥޟڋ็(6~17ྑ)ޟܹ
ܒၐᡛϛȂ60.3%(199/330)ׇԙΙԑޟOTSUKA ABILIFYݽᕛȄڧ຺ႆ9এТݽᕛޟҁ
֯ᡝ१ᡐϽϞZ0.26এྥ৯(SD)Ȅ
ڧݽᕛޟڋ็Ȃᔖᅿڏᡝ१ቨёٮຟեШᄇғலҡߝϞᡝ१ቨёޟኇȄ
5.7 ॾဘؒተిַ֏઼͂࡞ؒڟїߏ
ΰѿࡣϞൢਰٽϛȂෆԤ݈Ңaripiprazoleޟีҡ੨ޟፐଢ଼Ȃ੫տ፰ിЅฒ ݲڙٲፐଢ଼ȄڏтൢᓜၶճϞफ़ܒޟፐଢ଼ȂѓࢂȈफ़ܒܒፐଢ଼ȃफ़ܒᗊ ސȃफ़ܒॵܖኸኸॵȃЅڏтፐଢ଼ܒޟܖफ़ܒޟ࣏ȄӰ࣏џฒݲᒱտ
ٲல࣏ȂПޱᔖ੫տඪᒺܖڏྱ៖ޱݧཎȂܻ݈ҢaripiprazoleਢȂџю ౪ཱིቨޟܖёቑޟ፰ിፐଢ଼ȃफ़ܒܒፐଢ଼ȃफ़ܒᗊސȃኸኸॵܖफ़ܒॵȂܖ ڏтޟፐଢ଼Ȅᔖݧཎޟᆍፐଢ଼ڙޟޑȂџᇄনีԤᜰȄ࢚ٲਰӇȂٮߨ ӒഋȂٲፐଢ଼ӵ६ճᏘ໔ܖୄࡣࣱོୄХȄषҐཎᜋڗٲफ़ܒޟ࣏ȂџᏲ मҏ٘ڷтΡޟ༌Ȅषю౪ٲฒݲڙޟፐଢ଼ȂᔖՃኌ६ճᏘ໔ܖୄȄ
5.8 ڢγؒѳіᐆ
OTSUKA ABILIFYџོЕีޢҳܒճՖᔆȂζ೨Ӱ࣏ѺڎԤ͗1ΰဝશڧᡝࡼ
תհҢޟጢ࢈ȄӵԊኑᏘᄇྱၐᡛϛȂٺҢο݈OTSUKA ABILIFYݽᕛϞԙΡޱ (n=2467)ϛޟޢҳܒճՖᔆࣺᜰٱӇีҡ(OTSUKA ABILIFYಢีҡȂԊኑᏘಢีҡ
)Ϸտ࣏ޢҳܒճՖᔆ(1%Ȃ0.3%)ȃ࠼༖ܒཷઌ(0.5%Ȃ0.3%)ȃоЅཷീ(0.5%Ȃ0.4%) ȇӵٺҢο݈OTSUKA ABILIFYݽᕛޟ6Ս18ྑޟڋ็ޱ(n=732)ϛϷտ࣏ޢҳܒճՖ ᔆ(0.5%Ȃ0%)ȃ࠼༖ܒཷઌ(0.4 %Ȃ0%)ȃоЅཷീ(0.2 %Ȃ0%)Ȅ
OTSUKA ABILIFYಢϛޟՖᔆю౪݂ᡗޢҳܒᡐϽ(ۡဎ࣏ҳ՝ᔮกڷ՝ᔮกࣺШၶȂ ԝᕻᔆ६ճయԽؒ࢘ȂиЖၰഀЀଽ ޟีҡڷԊኑᏘಢࣺШၶٮฒӈդԤཎဎޟ ৯(OTSUKA ABILIFYಢีҡȂԊኑᏘಢีҡ)ȈӵٺҢο݈OTSUKA ABILIFYݽᕛޟ ԙΡޱϛ࣏(4%Ȃ2%)ȂӵٺҢο݈OTSUKA ABILIFYݽᕛޟ6Ս18ྑޟڋ็ޱϛ࣏(0.4%
Ȃ1%)Ȅ
OTSUKA ABILIFYᔖ၎੫տݧཎٺҢܻԤϐޣήक़ϞȈЖՖᆓ(ЖՊఠ༬ȃી
ՖܒЖȃЖ૾ᆑܖ༈ᏲலϞѬ)ȂသՖᆓȂܖོٺҡճՖᔆޟל(
ಳЫȃՖৠᑖЍȂоЅ݈Ң६Ֆᔆޟݽᕛ)Ȅ[َސҺϣհҢ(7.1)]Ȅ
5.9 Ωі୨̍ăพ˛ؒΩі୨̍ăؒΩі୨ী̼ॿ
ӵᖝחၐᡛڷ/ܖΰѿࡣޟငᡛϛȂਢܒᇄתᆠડސ(ѓࢂOTSUKA ABILIFY)ԤᜰԃҩՖ ౨Ѝڷ༞ϛܒҩՖ౨ЍޟٱӇෆငԤኺޟൢ֙ȄಖܒҩՖ౨ીмζෆငೝൢ֙ႆȄ ҩՖ౨Ѝڷ༞ϛܒҩՖ౨ЍޟџޟӠᓎӰશѓࢂϐԆӵޟճҩՖ౨(WBC)ኵ/๘ᄇ༞ϛܒ ҩՖ౨(ANC)ኵڷࠢഅԙޟҩՖ౨Ѝڷ༞ϛܒҩՖ౨ЍޟᐣѬȄෆငԤႆᖝחΰᡗޟ ճҩՖ౨(WBC)ኵ/ANCܖࠢഅԙޟҩՖ౨Ѝڷ༞ϛܒҩՖ౨Ѝޟӵݽᕛۖശߑ ޟඁএТ҆ငலᅿกӒՖՖ౨ॎኵ(CBC)ȇӵؠԤڏтޟনӰϞήȂ࿋ᖝחΰᡗޟҩՖ౨ (WBC)ኵ६ճޟΙၬຫю౪ਢȂᔖ၎ՃኌڗୄҢOTSUKA ABILIFYȄ
ԤᖝחΰᡗޟҩՖ౨Ѝ҆ωЖӴᅿกีᐶܖڏтޑܖཐӐȂषԤኺޟޑ ܖӐȂҳ։ݽᕛȄԤᝒ१ޟ༞ϛܒҩՖ౨Ѝ(༞ϛܒҩՖ౨๘ᄇኵɴ1000/mm3)Ȃ҆
ୄҢOTSUKA ABILIFYՄиଡᙹWBCޢڗඈȄ
5.10 ᝪᱚവѰ/ര
ӵȃԊኑᏘᄇྱޟၐᡛϛȂԤᡪゕѬϚѓࢂᡪゕ/ะᠿޟีҡȂӵҐጂຨޟԙΡ
ο݈OTSUKA ABILIFYԤ0.1% (3/2467)Ȃӵڋ็Ȟ6Ս18ྑȟԤ0.1% (1/732)Ȅ ԃӣڏтתᆠડސȂٺҢOTSUKA ABILIFYਢौݧཎԤᡪゕѬޟܖџ६ճᡪ ゕีհ⿉ޟޑݷȄ65ྑܖоΰఊတȂџШၶৠܾีҡᡪゕ⿉६ճޟלȄ
5.11 ჯڣོ̅ʨ֧ڟؒ͟
ڷڏѺޟתᆠડސΙኺȂOTSUKA ABILIFYζџོཬրᘞȃࡦՃܖၼଢ଼ޟΨȄٽ ԃȂӵޟԊኑᏘᄇྱၐᡛϛȂю౪༞ᆃ(ѓࢂᚊᓗ)౪ຫޟൢԃή(OTSUKA ABILIFY ಢีҡȂԊኑᏘಢีҡ)ȈӵٺҢο݈OTSUKA ABILIFYݽᕛޟԙΡޱ(n=2467)ϛ࣏
(11%Ȃ6%)Ȃӵ6Ս17ྑޟڋ็ޱ(n=611)ϛ࣏(24%Ȃ6%)ȄӵޟԊኑᏘᄇྱၐᡛϛȂӰ ю౪༞ᆃ(ѓࢂᚊᓗ)౪ຫՄᏲमୄޟШȂӵٺҢο݈OTSUKA ABILIFYݽᕛޟԙΡ
ޱϛ࣏0.3% (8/2467)Ȃӵڋ็ޱ(6Ս18ྑ)ϛ࣏3% (20/732)Ȅ
ᗶณٲٱӇޟีҡڷԊኑᏘಢࣺШၶޟࣺᄇЀଽแ࡙ٮϚσȂϫᔖ֙ᇰޱϚौᐇհ Ӡᓎᐠడ(ѓࢂءٙ)Ȃޢڗтঈࣺ࿋ጂۡٺҢOTSUKA ABILIFYݽᕛϚོᄇтঈഅԙϚيኇ
࣏ХȄ
5.12 ຣቡ
תᆠડސೝᇯ࣏ڎԤકᚽ٘ᡝՌ٘६ճਯЖᡝྣޟΨȄԃݎौПOTSUKA ABILIFY
џܻӨᆍོᏲमਯЖᡝྣЀଽϞݷ(፝ԃቑ੨ၼଢ଼ȃᛊ៩ӵྃዥޟᕗცȃӣਢ݈Ңת ᖚᢃܒޟސȂܖৠܾಳЫ)ޟȂᔖϠᎌ࿋ྱ៖ [َϚيІᔖ(6.3)]Ȅ
5.13 ьମ
ᆠડலȃᚖྃܒЅ१၇Ȃনҏ൷џѓ֤ՌమཎყȂଽӠᓎတᔖ၎ौ
ӣਢڧᝒޟᅿڷސݽᕛȄПശωᏘ໔ޟOTSUKA ABILIFYȂٮиᎌϸޟ
ညȂоЍ݈ႆ໔ޟॳᓎ[َϚيІᔖȞ6.1Ѕ6.2)]Ȅ
5.14 ҍᖼҨᘲ
ॵၾឆଢ଼Ϛيڷা༧Ȃϐޣᇄתᆠડސ(ѓࢂOTSUKA ABILIFY)ϞٺҢԤᜰȄ֜Σܒ
އԑߝϞலَޟӰڷԫӰȂ੫տԤ१࡙ߡ૭ᓶЪѶසޟȄӵџี
ҡ֜Σܒއޟ٘ΰȂOTSUKA ABILIFYᇄڏтתᆠડސᔖ၎ᙱབٺҢ[َឌᇭڷ ݧཎٱ(5.1)ЅϚيІᔖ(6.2)]Ȅ
7!˚Պ̆ᐖ
ҥܻᖝחၐᡛޟ໌నӇ৯ྃσȂӵΙᆍࠢϞᖝחၐᡛϛܚᢎᄆڗޟϚيІᔖϚџޢ
ڷѪΙᆍࠢᖝחၐᡛޟϚيІᔖ໌ШၶȂζџฒݲІࢎᖝחᄂϛܚَޟีҡ
Ȅ
ήӖϚيІᔖٷԪҽϞڏтհߖΙ؏ޟଆ፣Ȅ
ҢܻԤѶසࣺᜰᆠડޟՂԑԫιЀଽ[َ༃ឌᇭЅឌᇭڷݧཎٱ(5.1)]
သՖᆓϚيٱӇȂѓࢂϛॳ [َ༃ឌᇭЅឌᇭڷݧཎٱ(5.2)]
ڋ็ȂߧЍԑᇄԑሆԙΡՌమ܈ᓞᇄՌమ࣏[َ༃ឌᇭЅឌᇭڷݧཎٱ(5.3)]
תᆠડސඌܒঐတ(NMS) [َឌᇭڷݧཎٱ(5.4)]
ᒶีܒၼଢ଼֨ᜲ [َឌᇭڷݧཎٱ(5.5)]
ཱིങфᗂᡐϽ[َឌᇭڷݧཎٱ(5.6)]
ᄘܒ፰ിڷڏтफ़ܒ࣏[َឌᇭڷݧཎٱ(5.7)]
ޢҳܒճՖᔆ [َឌᇭڷݧཎٱ(5.8)]
ҩՖ౨Ѝȃ༞ϛܒҩՖ౨ЍȃಖܒҩՖ౨ીм [َឌᇭڷݧཎٱ(5.9)]
ᡪゕีհ/ะᠿ [َឌᇭڷݧཎٱ(5.10 )]
ᇯޣЅၼଢ଼Ψڧཬޟџܒ [َឌᇭڷݧཎٱ(5.11 )]
ᡝྣ፡ [َឌᇭڷݧཎٱ(5.12 )]
Ռమ [َឌᇭڷݧཎٱ(5.13)]
֍ᚼ֨ᜲ [َឌᇭڷݧཎٱ(5.14)]
ԙΡᖝחၐᡛϛȂശலَ ޟϚيІᔖԤ⭱Жȃმӥȃ߯ફȃᓞฮȃཷઌȃᓗֲϚ
ȃฐኌȃѶЅฐនϚԊȄ
ڋ็ᖝחၐᡛϛȂശலَ ޟϚيІᔖԤ༞ᆃȃᓞฮȃმӥȃᓅᡝѴ৷ޑȃ
ॾȃॵናቨёȃѶȃ⭱ЖȃቅࠠއЅᡝ१ቨёȄ
OTSUKA ABILIFYޟԊӒܒϐӵ13543՝ޟࡦឈѶ፡ȃᚖྃܒȃ१ȂЅߡ૭ᓶ
ѶසΡᇄӻᏘ໔ݽᕛޟᖝחၐᡛϛёоຟեȈٲᄇܻο݈OTSUKA ABILIFYޟᛊ៩໔࣏7619Ρ-ԑ[patient-year]ȄᖂॎԤ3390՝ڧο݈OTSUKA ABILIFY
ՍЍ180РȂԤ1933՝ο݈OTSUKA ABILIFYՍЍΙԑȄ
OTSUKA ABILIFYޟԊӒܒϐӵ1686՝ޟࡦឈѶ፡ȃᚖྃܒȃՌഖܒܖׂ࿅
Ъޱ(6Ս18ྑ)ᇄӻᏘ໔ݽᕛޟᖝחၐᡛϛёоຟեȈٲᄇܻο݈OTSUKA ABILIFYޟᛊ៩໔࣏1342Ρ-ԑȄᖂॎԤ959՝ڋ็ڧο݈OTSUKA ABILIFYՍЍ180 РȂԤ556՝ڋ็ο݈OTSUKA ABILIFYՍЍΙԑȄ
ٺҢOTSUKA ABILIFYݽᕛ(ΙސݽᕛЅתᏘܖᆱᛧۡᏘϞሄօݽᕛ)ޟޑݷڷਢ
Ȃѓࢂ(տԤ१᠒)ᚖޡȃШၶڷߨШၶܹܒंـȃ՞ڷߞຨϞंـȃھۡ
Ꮨ໔ڷኆܒᏘ໔ंـȂоЅڷߝޟᛊ៩ंـȄ
6.1 ᒝӗࠂՀ༄
ݦᚈͶቡॿ˞Йʡॾૉ
ӵ5এԊኑᏘᄇྱၐᡛ၇(4এ࣏4໊Ȃ1এ࣏6໊)Ȃο݈OTSUKA ABILIFYޟٺҢᏘ໔ጒ൜
࣏ؐР2~30యպȂுڗήӖี౪Ȉ લՎ˚Պ̆ᐖ
ӵٺҢOTSUKA ABILIFYݽᕛޟࡦឈѶ፡ϛȂ୲ΙலَޟϚيІᔖ(ีҡ࣏5%[֤]
оΰȂиӵOTSUKA ABILIFYಢޟีҡՍЍ࣏ԊኑᏘಢޟڍॻоΰ)ᓗֲϚ(akathisia)(
OTSUKA ABILIFYಢ࣏8%ȇԊኑᏘಢ࣏4%)Ȅ ᖖؒॽૉᚓॿവѰ˞Йʡॾૉ
ሣᗾڐٽᑛ
ӵ࣏3໊ȃԊኑᏘᄇྱၐᡛ၇Ȃο݈OTSUKA ABILIFYٺҢᏘ໔࣏ؐР15ܖ30యպȂுڗ ήӖี౪Ȉ
લՎ˚Պ̆ᐖ
ӵ݈ҢOTSUKA ABILIFYޟᚖྃܒនϛȂܚี౪ޟலَϚيІᔖ(ีҡ࣏5%[֤]
оΰȂиӵOTSUKA ABILIFYಢޟีҡՍЍ࣏ԊኑᏘಢޟڍॻоΰ)ԃߒ14ܚӖȄ ے14Ĉϵ഻ೈăЊᆑዘဇັཐཇĂ̾ʿوOTSUKA ABILIFY
ሣᗾڐٽᑛᖖؒॽૉᚓॿЙʡॾૉʰؚവ୪ڟલՎ˚Պ̆ᐖ
ౢ˚Պ̆ᐖڟॾૉ̨ս OTSUKA ABILIFY Њᆑዘ
લච (917ʡ) (753ʡ)
ᓗֲϚ 13 4
ᚊᓗ 8 3
ฐនϚԊ 6 3
ᓅᡝѴ৷ޑ 5 2
ᠬ 6 3
Йʡॾૉ˛ྲྀ˚લՎڟ˚Պ̆ᐖ
ߒ15Ӗᖞюӵࡨܒݽᕛ(ࡦឈѶ፡ߝႀ6໊ȇᚖྃܒនߝႀ3໊)ܚีҡޟϚيІᔖޟ ᆣӫีҡ(ڥڗശߖޟᐌኵԻϷШ)Ȃծ༉ѓࢂٺҢOTSUKA ABILIFY(ؐРᏘ໔యպ) ݽᕛϞϛีҡ࣏2%(֤)оΰȂи၎ϚيІᔖϞีҡӵOTSUKA ABILIFYಢଽܻԊኑ ᏘಢޱȄ
ے
15Ĉϵ഻ೈăЊᆑዘဇັཐཇĂ̾ʿوOTSUKA ABILIFY
ٽᑛڟЙʡॾૉ˛ؚവΡ˞˚Պ̆ᐖౢ˚Պ̆ᐖڟॾૉ̨սa ዢעՁ˷ᘸ
લච
OTSUKA ABILIFY Њᆑዘ (1843ʡ) (1166ʡ)
ఋॽૉ
ຜឈጙ 3 1
ࠥ༗ॽૉ
⭱Ж 15 11
߯ફ 11 7
მӥ 11 6
ੑϽϚي 9 7
οୁ 5 4
бฮ 4 3
လഋϚᎌ 3 2
थഋϚᎌ 3 2
ϒؒ̆ᐖჄӹᗾఋѝ̆ᐖ
഼ 6 4
ઃฮ 3 2
ъш਼Ꮻ̅ൖሚᕑॽૉ
ՊՈ଼ᓫቊ 4 3
Ѳઃฮ 4 2
Պฮ 2 1
ՊՈะᠿ 2 1
ড༄Ձॽૉ
ᓞฮ 27 23
ཷઌ 10 7
ᓗֲϚ 10 4
ᚊᓗ 7 4
ᓅᡝѴ৷ޑ 5 3
ᠬ 5 3
༞ᆃ 5 3
Ⴀডॽૉ
ᐭଢ଼ޑ 19 17
Ѷ 18 13
ฐኌ 17 13
ฐនϚԊ 5 3
ֳҜՁăఋ̅Ⴞॽૉ
ࠠ൙ฮ 3 2
ࠝლ 3 2
aߒҰՍЍԤ2%ο݈OTSUKA ABILIFYϞൢޟϚيІᔖȂծϚѓࢂี
ҡ้ܻܖճܻԊኑᏘಢޟϚيІᔖȄ
ΙএବᄇΡοԩఊတޟၐᡛٮҐᡗҰϚӣԑឭȃܒտȃڷᆍఊϞϚيІᔖีҡԤᡗ৯
Ȅ
ᖖؒॽૉᚓॿവѰ˞Йʡॾૉڟᄄ҅ٽᑛ
ӵବᄇᚖྃܒԙΡȃԊኑᏘᄇྱၐᡛ၇Ȃ݈ҢOTSUKA ABILIFYޟᏘ໔࣏ؐР15ܖ 30యպհ࣏ᎤᢄܖvalproateϞሄօݽᕛȂுڗήӖี౪Ȉ
Ⴤዲᗾߺᘰڟ˚Պ̆ᐖ
ӵΙএϐငџоञڧᎤᢄܖvalproate࣏ΙݽᕛПԒϞᖝחၐᡛϛี౪ȂоOTSUKA ABILIFY࣏ሄօݽᕛПԒޟȂӰϚيІᔖՄᏲमୄޟีҡ࣏12%ȂՄоplacebo࣏ሄ օݽᕛПԒϞีҡ࣏6%Ȅ
ӵOTSUKA ABILIFYሄօݽᕛಢܖԊኑᏘሄօݽᕛಢϛȂᇄᏲमୄࣺᜰޟശலَޟϚي Іᔖ࣏ᓗֲϚ(ีҡϷտ࣏5%Ѕ1%)Ѕᠬ(ีҡϷտ࣏2%Ѕ1%)Ȅ
લՎ˚Պ̆ᐖ
ӵ݈ҢOTSUKA ABILIFYհ࣏ᎤᢄܖvalproateϞሄօᕛݲޟᚖྃܒនีհϛȂܚ
ี౪ޟலَϚيІᔖ(ีҡ࣏5%[֤]оΰȂиӵOTSUKA ABILIFYಢޟีҡՍЍ࣏ԊኑᏘ ಢޟڍॻоΰ)ԤᓗֲϚȃѶЅᓅᡝѴ৷ޑȄ
ᄄ҅ٽᑛЙʡॾૉᖖؒॽૉᚓॿྲྀ˚ؾവΡڟ˚Պ̆ᐖ
ߒ16Ӗᖞюӵࡨܒݽᕛ(ߝႀ6໊)ܚีҡޟϚيІᔖޟᆣӫีҡ(ڥڗശߖޟᐌኵԻ ϷШ)Ȃծ༉ѓࢂٺҢOTSUKA ABILIFY࣏Ꭴᢄܖvalproateሄօݽᕛ(ؐРᏘ໔15ܖ30యպ)ݽ ᕛϞϛีҡ࣏2%(֤)оΰȂи၎ϚيІᔖϞีҡӵԪOTSUKA ABILIFYёΰᎤᢄܖ valproateݽᕛಢӫޟଽܻԊኑᏘёΰᎤᢄܖvalproateሄօݽᕛޱȄ
ے16Ĉϵ഻ೈăЊᆑዘဇັཐཇĂպᄄ҅ᑛٲٽᑛᖖؒॽૉᚓॿ ॾૉ˛ؚവΡ˞˚Պ̆ᐖ
ౢ˚Պ̆ᐖڟॾૉ̨սa OTSUKA ABILIFY Њᆑዘ ዢעՁ˷ᘸ
લච
+ Li or Val* + Li or Val*
(253ʡ) (130ʡ)
ࠥ༗ॽૉ
⭱Ж 8 5
მӥ 4 0
శϷݪႆӻ 4 2
οୁ 2 1
๐ޗჄચΡᕫۭޗ
ቅࠠއ 3 2
ቡޥࠂՀ
ᡝ१ቨё 2 1
ড༄Ձॽૉ
ᓗֲϚ 19 5
ᠬ 9 6
ᓅᡝѴ৷ޑ 5 1
ཷઌ 4 1
ᚊᓗ 4 2
Ⴀডॽૉ
Ѷ 8 4
ฐኌ 4 1
ฐនϚԊ 2 1
aߒҰՍЍԤ2%ο݈OTSUKA ABILIFYϞൢޟϚيІᔖȂծϚѓࢂ
ีҡ้ܻܖճܻԊኑᏘಢޟϚيІᔖȄ *Ꭴᢄܖvalproate
ݦᚈͶቡॿ˞േॾૉ(13э17ຑ)
ӵΙএ࣏6໊ȃԊኑᏘᄇྱၐᡛ၇Ȃο݈OTSUKA ABILIFYޟᏘ໔࣏ؐР2Ս30యպȂுڗ ήӖี౪Ȉ
Ⴤዲᗾߺᘰڟ˚Պ̆ᐖ
ӵݽᕛڋ็(13Ս17ྑ)ਢȂOTSUKA ABILIFYಢЅԊኑᏘಢӰϚيІᔖՄᏲमୄޟี
ҡϷտ࣏5%Ѕ2%Ȅ લՎ˚Պ̆ᐖ
ӵ݈ҢOTSUKA ABILIFYݽᕛߧЍԑࡦឈѶ፡ਢȂܚี౪ޟலَϚيІᔖ(ีҡ࣏5%[֤]
оΰȂиӵOTSUKA ABILIFYಢޟีҡՍЍ࣏ԊኑᏘಢޟڍॻоΰ)࣏ᓅᡝѴ৷ޑȃ༞ᆃ ЅᠬȄ
ᖖؒॽૉᚓॿവѰ˞േॾૉ(10э17ຑ)
ӵΙএ࣏4໊ȃԊኑᏘᄇྱၐᡛ၇Ȃο݈OTSUKA ABILIFYޟᏘ໔࣏ؐР10ܖ30యպȂு
ڗήӖี౪Ȉ
Ⴤዲᗾߺᘰڟ˚Պ̆ᐖ
ӵݽᕛڋ็(10Ս17ྑ)ਢȂOTSUKA ABILIFYಢЅԊኑᏘಢӰϚيІᔖՄᏲमୄޟี
ҡϷտ࣏7%Ѕ2%Ȅ લՎ˚Պ̆ᐖ
ӵ݈ҢOTSUKA ABILIFYݽᕛᚖྃܒនีհϞڋ็(10Ս17ྑ)ਢȂܚี౪ޟலَ
ϚيІᔖ(ีҡ࣏5% [֤]оΰȂиӵOTSUKA ABILIFYಢޟีҡՍЍ࣏ԊኑᏘಢޟڍॻ оΰ)ԃߒ17ܚӖȄ
ے17Ĉϵ഻ೈăЊᆑዘဇັཐཇĂʿوOTSUKA ABILIFYٽᑛ ᖖؒॽૉᚓॿേॾૉ
(10э17ຑ)ؚവΡ˞લՎ˚Պ̆ᐖ
ౢവΡ˚Պ̆ᐖڟॾૉ̨ս OTSUKA ABILIFY Њᆑዘ
લච (n=197) (n=97)
༞ᆃ 23 3
ᓅᡝѴ৷ޑ 20 3
ॾ 11 4
⭱Ж 11 4
ᓗֲϚ 10 2
ຜឈጙ 8 0
శϷݪႆӻ 6 0
ཷઌ 5 1
ьఖؒॽૉ˞േॾૉ(6э17ຑ)
ӵڍএ࣏8໊ȃԊኑᏘᄇྱၐᡛ၇ȂOTSUKA ABILIFYޟο݈Ꮨ໔࣏ؐР2ڗ15యպȂுڗ ήӖี౪Ȉ
Ⴤዲᗾߺᘰڟ˚Պ̆ᐖ
ӵݽᕛڋ็(6Ս17ྑ)ਢȂOTSUKA ABILIFYಢЅԊኑᏘಢӰϚيІᔖՄᏲमୄޟีҡ
Ϸտ࣏10%Ѕ8%Ȅ લՎ˚Պ̆ᐖ
ӵ݈ҢOTSUKA ABILIFYݽᕛՌഖܒϞڋ็(6Ս17ྑ)ਢȂܚี౪ޟலَϚيІᔖ (ีҡ࣏5% [֤]оΰȂиӵOTSUKA ABILIFYಢޟีҡՍЍ࣏ԊኑᏘಢޟڍॻоΰ)ԃߒ 18ܚӖȄ
ے18Ĉϵ഻ೈăЊᆑዘဇັཐཇĂʿوOTSUKA ABILIFYٽ ᑛьఖؒॽૉേॾૉ
(6э17ຑ)ؚവΡ˞લՎ˚Պ̆ᐖ
ౢവΡ˚Պ̆ᐖڟॾૉ̨ս OTSUKA ABILIFY Њᆑዘ
લච (n=212) (n=101)
ᚊᓗ 21 4
ॾ 17 2
მӥ 14 7
༞ᆃ 10 4
ᠬ 10 0
ีᐶ 9 1
ࢺοЫ 9 0
ॵና६ճ 7 2
శϷݪႆӻ 6 1
ᓅᡝѴ৷ޑ 6 0
݄ᆃ 5 0
ӂ̪ॿ˞േॾૉ(6э18ຑ)
ӵΙএ࣏8໊ڷѪΙএ࣏10໊ޟԊኑᏘᄇྱၐᡛ၇ȂOTSUKA ABILIFYޟο݈Ꮨ໔࣏ؐ
Р2ڗ20యպȂுڗήӖี౪Ȉ Ⴤዲᗾߺᘰڟ˚Պ̆ᐖ
ڋ็(6~18ྑ)ϛӰհҢՄୄҢސޟШȂӵOTSUKA ABILIFYݽᕛಢᇄԊኑᏘಢϷ տ࣏7%ڷ1%Ȅ
લՎ˚Պ̆ᐖ
ӵ݈ҢOTSUKA ABILIFYݽᕛׂ࿅ЪϞڋ็ਢȂܚี౪ޟலَϚيІᔖ(ีҡ࣏5%
[֤]оΰȂиӵOTSUKA ABILIFYಢޟีҡՍЍ࣏ԊኑᏘಢޟڍॻоΰ)ԃߒ19ܚӖȄ ے19Ĉϵ഻ೈăЊᆑዘဇັཐཇĂʿوOTSUKA ABILIFYٽᑛӂ̪ॿ˞േ
ॾૉ
(6э18ຑ)ؚവΡ˞લՎ˚Պ̆ᐖ
ౢവΡ˚Պ̆ᐖڟॾૉ̨ս OTSUKA ABILIFY Њᆑዘ
લච (n=121) (n=72)
ᚊᓗ 13 6
༞ᆃ 13 1
⭱Ж 11 4
ᓞฮ 10 3
ቅࠠއ 9 0
ॾ 8 0
ॵናቨё 7 1
ݦᚈͶቡॿăᖖؒॽૉᚓॿăьఖؒॽૉؖӂ̪ॿ˞േॾૉ(6э18ຑ)˛ྲྀ˚લՎڟ˚
Պ̆ᐖ
ߒ20ӖᖞΟࡨܒݽᕛ(ࡦឈѶ፡ശߝݽᕛ6໊Ȃᚖྃܒនശߝݽᕛ4໊ȂՌഖܒ
ശߝݽᕛ8໊Ȃׂ࿅Ъശߝݽᕛ10໊)ܚีҡϞϚيІᔖޟᆣӫีҡ(ڥڗശߖޟ ᐌኵԻϷШ)Ȃծ༉ѓࢂӵٺҢOTSUKA ABILIFY (Ꮨ໔యպ/Р)ݽᕛϞڋ็ϛޟีҡ
࣏2% (֤)оΰȂиӵٺҢOTSUKA ABILIFYݽᕛϞޱϛޟีҡौଽܻٺҢԊኑᏘݽ ᕛϞޱޟีҡȄ
ے
20Ĉϵ഻ೈăЊᆑዘဇັཐཇĂʿوOTSUKA ABILIFYٽᑛേॾૉ
(6э18ຑ)ؚവΡ˞ྲྀ˚લՎڟ˚Պ̆ᐖ
ౢവΡ˚Պ̆ᐖڟॾૉ̨սa ዢעՁ˷ᘸ OTSUKA ABILIFY Њᆑዘ
લච (n=732) (n=370)
ఋॽૉ
ຜឈጙ 3 0
ࠥ༗ॽૉ
थഋϚᎌ 2 1
მӥ 8 7
⭱Ж 8 4
လᘬ 4 3
శϷݪႆӻ 4 1
ΰလઃฮ 3 2
߯ફ 2 2
ϒؒ̆ᐖჄӹᗾఋѝ̆ᐖ
ॾ 10 2
ีᐶ 4 1
ࡨនܾࡥ 2 1
ฒΨ 2 1
๐ޗჄચΡᕫۭޗ
ቅࠠއ 6 3
ቡޥࠂՀ
ᡝ१ቨё 3 1
̈́ᓂჄᑊኴॽૉ
ॵናቨё 7 3
ॵና६ճ 5 4
ъш਼Ꮻ̅ൖሚᕑॽૉ
ՊՈ଼ᓫቊ 2 1
ՊՈቊ 2 1
ড༄Ձॽૉ
༞ᆃ 16 4
ᓞฮ 12 10
ᚊᓗ 9 2
ᠬ 9 1
ᓅᡝѴ৷ޑ 6 1
ᓗֲϚ 6 4
ࢺοЫ 3 0
݄ᆃ 3 0
ཷઌ 3 2
ՊΨல 2 1
ֳҜՁăఋ̅Ⴞॽૉ
ቅюՖ 2 1
Ϊሳ̅Ϊʮᕑॽૉ
Ҫ 2 1
a ӵٺҢο݈OTSUKA ABILIFYݽᕛϞڋ็ϛޟൢՍЍ࣏2%ޟϚي ІᔖȂծϚѓࢂีҡ้ܻܖճܻԊኑᏘಢޟϚيІᔖȄ
պOTSUKA ABILIFYੈߏࡧឮॿ˞ᄄ҅ٽᑛᗾڟЙʡॾૉ
ήӖี౪ޟٷᐃ࣏ڍএବᄇ१ޱٺҢ2యպՍ20యպϞOTSUKA ABILIFYୈ࣏ࡻ៉ת
ᏘݽᕛϞሄօݽᕛҢޟԊኑᏘᄇྱၐᡛޟᆣӫϷݙ๖ݎȄ ዲ̥ٽᑛڟ˚Պ̆ᐖ
ӵڧOTSUKA ABILIFYሄօݽᕛޟޱϛȂӰϚيІᔖՄୄХݽᕛޟีҡ࣏6%Ȃӵڧ ԊኑᏘሄօݽᕛޟޱϛࠌ࣏2%Ȅ
લՎڟ˚Պ̆ᐖ
ӵٺҢOTSUKA ABILIFYୈ࣏ሄօݽᕛޟ१ޱϛȂܚี౪ޟலَϚيІᔖ(ีҡ࣏
5% [֤]оΰȂиOTSUKA ABILIFYಢޟีҡՍЍ࣏ԊኑᏘಢޟڍॻ)࣏ᓗֲϚȃྮនϚ ԊȃѶȃ߯ફȃॾȃоЅຜឈጙȄ
ࡧឮॿЙʡॾૉ˛ྲྀ˚લՎڟ˚Պ̆ᐖ
ߒ21ӖᖞΟࡨܒݽᕛ(ശߝ6໊)ܚีҡϞϚيІᔖޟᆣӫีҡ(ڥڗശߖޟᐌኵԻϷ Ш)Ȃծ༉ѓࢂӵڧOTSUKA ABILIFYሄօݽᕛ(Ꮨ໔యպ/Р)Ϟޱϛޟีҡ࣏2%(֤) оΰȂиӵڧOTSUKA ABILIFYሄօݽᕛϞޱϛޟีҡौଽܻڧԊኑᏘሄօݽᕛϞ
ޱޟีҡȄ
ے
21Ĉਬဇࡧឮॿૉڱؚї˞഻ೈЊᆑዘဇັڟᄄ҅ٽᑛཐ˛വΡڟ˚Պ̆ᐖ
ౢവΡ˚Պ̆ᐖڟॾૉ̨սa ዢעՁ˷ᘸ OTSUKA ABILIFY+ADT* Њᆑዘ+ADT*
લච (n=371) (n=366)
ఋॽૉ
ຜឈጙ 6 1
ࠥ༗ॽૉ
߯ફ 5 2
ϒؒ̆ᐖჄӹᗾఋѝ̆ᐖ
ॾ 8 4
ᆧϚԊ 3 1
๐ޗჄચΡᕫۭޗ
ΰڳ֜ၾཐ 6 4
ቡޥࠂՀ
ᡝ१ቨё 3 2
̈́ᓂჄᑊኴॽૉ
ॵናቨё 3 2
ъш਼Ꮻ̅ൖሚᕑॽૉ
ᜰฮ 4 3
Պฮ 3 1
ড༄Ձॽૉ
ᓗֲϚ 25 4
༞ᆃ 6 4
ᠬ 5 4
ᚊᓗ 4 2
ཷઌ 4 2
ݧཎራᛤ 3 1
ᓅᡝѴ৷ޑ 2 0
Ⴀডॽૉ
ྮនϚԊ 12 2
Ѷ 8 2
a ӵڧOTSUKA ABILIFYሄօݽᕛϞޱϛޟൢՍЍ࣏2%ޟϚيІᔖȂծϚ ѓࢂีҡ้ܻܖճܻԊኑᏘಢޟϚيІᔖȄ
* תᏘݽᕛ
Ⴤዘුߺᘰڟ˚Պ̆ᐖ ݦᚈͶቡॿ
ंـΡষෆٷᐃྛՌѲএବᄇኵᆍϚӣھۡᏘ໔(2యպ/Рȃ5యպ/Рȃ10యպ/Рȃ15య պ/Рȃ20యպ/РȃоЅ30యպ/Р)Ϟο݈OTSUKA ABILIFYᇄԊኑᏘ໌ШၶϞࡦឈѶ፡
ԙΡၐᡛޟኵᐃȂຟեӵݽᕛю౪ϞϚيٱӇޟีҡޟᏘ໔Іᔖᜰ߽Ȅٷ
ंـϷቹޟϷݙᡗҰȂ୲ΙџڎԤᏘ໔Іᔖᜰ߽ޟϚيІᔖ࣏༞ᆃ[ѓࢂᚊᓗ]ȂٮиѫԤ ӵ30యպಢϛശ࣏݂ᡗ(ีҡϷտ࣏ԊኑᏘಢȂ7.1%ȇ10యպಢȂ8.5%ȇ15యպಢȂ8.7%
ȇ20యպಢȂ7.5%ȇ30యպಢȂ12.6%)Ȅ
ӵବᄇࡦឈѶ፡ڋ็(13Ս17ྑ)ܚ໌ޟंـϛȂԤέᆍலَޟϚيІᔖџڎԤ Ꮨ໔Іᔖᜰ߽ȈᓅᡝѴ৷ޑ(ีҡϷտ࣏ԊኑᏘಢȂ5.0%ȇ10యպಢȂ13.0%ȇ30యպ ಢȂ21.6%)ȇ༞ᆃ(ีҡϷտ࣏ԊኑᏘಢȂ6.0%ȇ10యպಢȂ11.0%ȇ30యպಢȂ21.6%)ȇ оЅᠬ(ีҡϷտ࣏ԊኑᏘಢȂ2.0%ȇ10యպಢȂ2.0%ȇ30యպಢȂ11.8%)Ȅ
ᖖؒॽૉᚓॿ
ӵᚖྃܒនڋ็(10Ս17ྑ)ޟंـϛȂ4໊ਢԤѲᆍலَޟϚيІᔖџڎԤ Ꮨ໔Іᔖᜰ߽ȈᓅᡝѴ৷ޑ(ีҡϷտ࣏ԊኑᏘಢȂ3.1%ȇ10యպಢȂ12.2%ȇ30యպ ಢȂ27.3%)ȇ༞ᆃ(ีҡϷտ࣏ԊኑᏘಢȂ3.1%ȇ10యպಢȂ19.4%ȇ30యպಢȂ26.3%)ȇ ᓗֲϚ(ีҡϷտ࣏ԊኑᏘಢȂ2.1%ȇ10యպಢȂ8.2%ȇ30యպಢȂ11.1%)ȇоЅశϷ ݪႆӻ(ีҡϷտ࣏ԊኑᏘಢȂ0%ȇ10యպಢȂ3.1%ȇ30యպಢȂ8.1%)Ȅ
ьఖؒॽૉ
ӵՌഖܒϞڋ็(6Ս17ྑ)ޟंـϛȂΙᆍலَޟϚيІᔖџڎԤᏘ໔Іᔖᜰ߽Ȉ
ॾ(ีҡϷտ࣏ԊኑᏘಢȂ0%ȇ5యպಢȂ3.8%ȇ10యպಢȂ22.0%ȇ15యպಢȂ18.5%) Ȅ
ӂ̪ॿ
ӵׂ࿅Ъڋ็(7~17ྑ)ޟၐᡛϛȂฒᇄᏘ໔ࣺᜰϞலَϚيІᔖȄ Ꮕʹࣷॿڑ
ݦᚈͶቡॿ
ࡦឈѶ፡ԙΡܚ໌ޟԊኑᏘᄇྱޟၐᡛȂൢีҡᓅᡝѴ৷ޑ(EPS)ࣺᜰٱ Ӈ(ϚѓࢂᓗֲϚࣺᜰٱӇ)ȂOTSUKA ABILIFYݽᕛಢޟีҡ࣏13%ȂԊኑᏘಢ࣏12%
ȇᓗֲϚࣺᜰٱӇȂOTSUKA ABILIFYݽᕛಢޟีҡ࣏8%ȂԊኑᏘಢ࣏4%ȄࡦឈѶ፡
ڋ็(13Ս17ྑ)໌ޟԊኑᏘᄇྱޟၐᡛȂൢีҡEPSࣺᜰٱӇ(ϚѓࢂᓗֲϚ
ࣺᜰٱӇ)ȂOTSUKA ABILIFYݽᕛಢޟีҡ࣏25%ȂԊኑᏘಢ࣏7%ȇᓗֲϚࣺᜰٱ ӇȂOTSUKA ABILIFYݽᕛಢޟีҡ࣏9%ȂԊኑᏘಢ࣏6%Ȅ
ٲၐᡛϛΝоSimpson Angus Rating Scales(ຟեEPS)ȃBarnes Akathisia Scale (ຟեᓗֲϚ
)ȃоЅAssessments of Involuntary Movement Scales (ຟեၼଢ଼ራᛤ)໌ຟեՄԝڗࡊᢎޟ ၥਟȄӵԙΡࡦឈѶ፡ၐᡛϛȂଶΟBarnes Akathisia Scaleޟຟե๖ݎ(OTSUKA ABILIFY ಢȂ0.08ȇԊኑᏘಢȂ-0.05)ϞѴȂڏѺࡊᢎԝڗޟኵᐃٮҐᡗҰOTSUKA ABILIFYᇄԊኑ ᏘԆԤӈդ৯Ȅӵڋ็(13Ս17ྑ)ࡦឈѶ፡ၐᡛϛȂଶΟSimpson Angus Rating Scaleޟ ຟե๖ݎ(OTSUKA ABILIFYಢȂ0.24ȇԊኑᏘಢȂ-0.29)ϞѴȂڏѺࡊᢎԝڗޟኵᐃٮҐ ᡗҰOTSUKA ABILIFYᇄԊኑᏘԆԤӈդ৯Ȅ
ӣኺӴȂӵΙএࡦឈѶ፡ԙΡܚ໌ޟߝ(26໊)ȂԊኑᏘᄇྱޟၐᡛϛȂցҢ Simpson Angus Rating Scale (for EPS)ȃBarnes Akathisia Scale (for Akathisia)ЅAssessments of Involuntary Movement Scales (for Dyskinesias) ໌ຟեՄࡊᢎԝڗޟኵᐃٮҐᡗҰOTSUKA ABILIFYᇄԊኑᏘԆԤӈդ৯Ȅ
ᖖؒॽૉᚓॿ
ӵᚖྃܒនԙΡܚ໌ޟԊኑᏘᄇྱޟၐᡛϛȂൢีҡEPSࣺᜰٱӇ(Ϛѓ
ࢂᓗֲϚࣺᜰٱӇ)ӵOTSUKA ABILIFYݽᕛಢีҡ࣏16%ȂԊኑᏘಢ࣏8%ȇᓗֲϚ
ࣺᜰٱӇӵOTSUKA ABILIFYݽᕛಢޟีҡ࣏13%ȂԊኑᏘಢ࣏4%ȄӵᚖྃនٺҢ OTSUKA ABILIFYୈ࣏ᎤᢄܖvalproateϞሄօݽᕛҢޟ6໊ȂԊኑᏘᄇྱޟၐᡛϛȂൢี
ҡEPSࣺᜰٱӇ(ϚѓࢂᓗֲϚࣺᜰٱӇ)ȂOTSUKA ABILIFYሄօݽᕛಢีҡ࣏15%ȂԊ ኑᏘሄօݽᕛಢ࣏8%ȇᓗֲϚࣺᜰٱӇȂOTSUKA ABILIFYሄօݽᕛಢޟีҡ࣏19%Ȃ ԊኑᏘሄօݽᕛಢ࣏5%Ȅӵᚖྃܒនڋ็(10Ս17ྑ)ܚ໌ޟԊኑᏘᄇྱޟ ၐᡛϛȂൢีҡEPSࣺᜰٱӇ(ϚѓࢂᓗֲϚࣺᜰٱӇ)ȂOTSUKA ABILIFYݽᕛಢޟี
ҡ࣏26%ȂԊኑᏘಢ࣏5%ȇᓗֲϚࣺᜰٱӇȂOTSUKA ABILIFYݽᕛಢޟีҡ࣏10%
ȂԊኑᏘಢ࣏2%Ȅ
ӵOTSUKA ABILIFYΙᕛݲޟԙΡᚖྃܒនၐᡛϛȂSimpson Angus Rating Scale ᇄBarnes Akathisia Scaleޟຟե๖ݎᡗҰOTSUKA ABILIFYᇄԊኑᏘԤ݂ᡗޟ৯(Ϸտ
࣏OTSUKA ABILIFYಢȂ0.50ȇԊኑᏘಢȂ-0.01оЅOTSUKA ABILIFYಢȂ0.21ȇԊኑᏘ ಢȂ-0.05)ȄӵAssessments of Involuntary Movement ScalesϛޟᡐϽП७ȂOTSUKA ABILIFY ಢᇄԊኑᏘಢޟߒ౪σमࣺ࿋ȄӵٺҢOTSUKA ABILIFYୈ࣏ᎤᢄܖvalproateϞሄօݽᕛҢ
ޟᚖྃܒនၐᡛϛȂSimpson Angus Rating ScaleᇄBarnes Akathisia Scaleޟຟե๖ݎᡗ ҰOTSUKA ABILIFYሄօݽᕛᇄԊኑᏘሄօݽᕛϞԤ݂ᡗޟ৯(Ϸտ࣏OTSUKA ABILIFY ಢȂ0.73ȇԊኑᏘಢȂ0.07оЅOTSUKA ABILIFYಢȂ0.30ȇԊኑᏘಢȂ0.11)ȄӵAssessments of Involuntary Movement ScalesϛޟᡐϽП७ȂOTSUKA ABILIFYሄօݽᕛಢᇄԊኑᏘሄօݽ ᕛಢޟߒ౪σमࣺ࿋Ȅӵڋ็(10Ս17ྑ)ᚖྃܒនၐᡛϛȂSimpson Angus Rating Scaleޟຟե๖ݎᡗҰOTSUKA ABILIFYᇄԊኑᏘԤ݂ᡗޟ৯(OTSUKA ABILIFYಢȂ0.90 ȇԊኑᏘಢȂ-0.05)ȄӵBarnes Akathisia ScaleᇄAssessments of Involuntary Movement Scalesϛ ޟᡐϽП७ȂOTSUKA ABILIFYಢᇄԊኑᏘಢޟߒ౪σमࣺ࿋Ȅ
ࡧឮॿ
ӵ१ޟԊኑᏘᄇྱޟၐᡛϛȂൢีҡEPSࣺᜰٱӇ(ϚѓࢂᓗֲϚࣺᜰٱӇ)Ȃ ӵOTSUKA ABILIFYሄօݽᕛಢޟีҡ࣏8%ȂԊኑᏘሄօݽᕛಢ࣏5%ȇᓗֲϚࣺᜰٱ ӇȂOTSUKA ABILIFYሄօݽᕛಢޟีҡ࣏25%ȂԊኑᏘሄօݽᕛಢ࣏4%Ȅ
ӵ१ၐᡛϛȂSimpson Angus Rating ScaleᇄBarnes Akathisia Scaleޟຟե๖ݎᡗҰ OTSUKA ABILIFYሄօݽᕛᇄԊኑᏘሄօݽᕛϞԤ݂ᡗޟ৯(Ϸտ࣏OTSUKA ABILIFY ಢȂ0.31ȇԊኑᏘಢȂ0.03оЅOTSUKA ABILIFYಢȂ0.22ȇԊኑᏘಢȂ0.02)ȄӵAssessments of Involuntary Movement ScalesϛޟᡐϽП७ȂOTSUKA ABILIFYሄօݽᕛಢᇄԊኑᏘሄօݽ ᕛಢޟߒ౪σमࣺ࿋Ȅ
ьఖؒॽૉ
ӵՌഖܒڋ็(6Ս17ྑ)ޟԊኑᏘᄇྱޟၐᡛϛȂൢีҡEPSࣺᜰٱӇ(Ϛѓࢂ
ᓗֲϚࣺᜰٱӇ)ȂӵOTSUKA ABILIFYݽᕛಢޟีҡ࣏18%ȂԊኑᏘݽᕛಢ࣏2%ȇᓗ
ֲϚࣺᜰٱӇȂOTSUKA ABILIFYݽᕛಢޟีҡ࣏3%ȂԊኑᏘݽᕛಢ࣏9%Ȅ ӵՌഖܒڋ็(6Ս17ྑ)ޟၐᡛϛȂSimpson Angus Rating Scale ޟຟե๖ݎᡗҰ OTSUKA ABILIFYݽᕛᇄԊኑᏘݽᕛϞԤ݂ᡗޟ৯(Ϸտ࣏OTSUKA ABILIFYಢȂ0.1ȇ ԊኑᏘಢȂ-0.4)ȄӵBarnes Akathisia Scale Ѕ Assessments of Involuntary Movement Scalesϛޟ ᡐϽП७ȂOTSUKA ABILIFYݽᕛಢᇄԊኑᏘݽᕛಢޟߒ౪σमࣺ࿋Ȅ
ӂ̪ॿ
ӵׂ࿅Ъڋ็(6~18ྑ)ϞԊኑᏘᄇྱၐᡛϛȂൢีҡEPSࣺᜰٱӇ(Ϛѓࢂᓗֲ
