JPWO2020212952A5 - - Google Patents
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- JPWO2020212952A5 JPWO2020212952A5 JP2021561958A JP2021561958A JPWO2020212952A5 JP WO2020212952 A5 JPWO2020212952 A5 JP WO2020212952A5 JP 2021561958 A JP2021561958 A JP 2021561958A JP 2021561958 A JP2021561958 A JP 2021561958A JP WO2020212952 A5 JPWO2020212952 A5 JP WO2020212952A5
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上述のものは、本発明の例示説明であり、その限定として解釈されるべきでない。本発明は、その中に含まれる請求項の均等物と共に、以下の請求項によって定義される。
特定の実施形態では、例えば、以下が提供される:
(項目1)
うつ病の治療を必要とする対象におけるうつ病を治療する方法であって、前記対象に、有効量のサイロシビンまたはその活性代謝産物を投与することを含む、前記方法。
(項目2)
前記対象が、大うつ病性障害、非定型うつ病、双極性障害、緊張病性うつ病、医学的状態に起因するうつ病性障害、分娩後うつ病、月経前不快気分障害、または季節性情動障害を有する、項目1に記載の方法。
(項目3)
前記対象が、大うつ病性障害を有する、項目2に記載の方法。
(項目4)
前記対象が、双極性障害を有する、項目2に記載の方法。
(項目5)
前記対象が、双極性障害I型を有する、項目4に記載の方法。
(項目6)
前記対象が、双極性障害II型を有する、項目4に記載の方法。
(項目7)
前記うつ病が、治療に対して抵抗性である、項目1~6のいずれか一項に記載の方法。
(項目8)
うつ病の少なくとも1つの兆候または症状が、低減される、項目1~7のいずれか一項に記載の方法。
(項目9)
前記うつ病の兆候または症状が、抑うつ気分、活動への関心の低下、体重減少もしくは増加、食欲の低下もしくは増加、不眠症もしくは過眠症、精神運動性激越もしくは遅延、疲労もしくはエネルギーの喪失、無価値感もしくは過度もしくは不適切な罪悪感、集中力の低下もしくは決断力の欠如、または自殺念慮もしくは行動である、項目8に記載の方法。
(項目10)
前記うつ病の兆候または症状が、日記評価、臨床医もしくは介護士による評価、臨床評価スケールに従って、または機能的MRIによって測定される、項目9に記載の方法。
(項目11)
前記臨床うつ病評価スケールが、簡易抑うつ症状尺度(QIDS)-16スケール、QIDS-16日常スケール、ハミルトンうつ病評価スケール、Beckうつ病インベントリスケール、Montgomery-Asbergうつ病評価スケール、臨床グローバル印象スケール、Zung自己評価うつ病スケール、Raskinうつ病評価スケール、及び/またはヤングマニア評価スケールである、項目10に記載の方法。
(項目12)
前記うつ病の兆候または症状が、Spielbergerの特質及び不安インベントリ、全般性不安障害7項目スケール、Warwick-Edinburghメンタルウェルビーイングスケール、Flourishingスケール、Snaith Hamilton快感消失喜びスケール、ライフオリエンテーションテスト、人生の意義質問票、ブリーフレジリエンススケール、非機能的態度スケール、44項目のビッグファイブインベントリ、ピーターズ21項目の妄想インベントリ、異常な自己経験の検査、考え込み型反応スケール、シロクマ抑制インベントリ、バレット衝動性スケール、簡易の体験的回避質問票、改変Tellegen没頭質問票、治療的関係を評価するためのスケール、信頼性/期待度質問票、自然とのつながりスケール、政治的展望質問票、社会的つながりスケール、Bech-Rafaelsenマニア評価スケール、改訂されたSanta Clara簡潔な思いやりスケール、感謝の質問票、短い推奨度スケール、Rosenberg自尊心スケール、精神的超越スケールの普遍性サブスケール、抗うつ剤の感情的な副作用に関するオックスフォード質問票、Lauks感情強度スケール、性機能障害質問票、女性の性機能の簡潔な指標、性認識質問票、Barnes Akathisia評価スケール、作業生産性及び活動障害質問票、仕事及び社会的適応度スケール、つながり質問票、人格の標準評価、陽性及び陰性症候群スケール、マスタリーインサイトスケール、自己省察(Self-Reflection)及びインサイトスケール、心理学的インサイトスケール、形而上学的信念質問票、スピリチュアルバイパス(Spiritual Bypassing)スケール、有害な幼少期経験質問票、治療音楽体験質問票、設定質問票、音楽没頭スケール、サイケデリック予測因子(Psychedelic Predictor)スケール、降伏スケール、EuroQOL-5次元-3レベルスケール、コロンビア自殺重症度評価スケール、自殺念慮属性スケール、またはこれらの任意の組み合わせを使用して測定される、項目10に記載の方法。
(項目13)
前記機能的MRIが、扁桃体の血液酸素レベル依存性(BOLD)反応を測定する、項目10に記載の方法。
(項目14)
前記BOLD反応が、安静状態で、感情的な顔、及び/または快楽刺激としての音楽に応答して測定される、項目13に記載の方法。
(項目15)
うつ病の少なくとも1つの兆候または症状が、前記サイロシビンの投与から24時間以内に緩和される、項目1~14のいずれか一項に記載の方法。
(項目16)
うつ病の少なくとも1つの症状が、前記サイロシビンの投与から1週間以内に緩和される、項目1~14のいずれか一項に記載の方法。
(項目17)
うつ病の少なくとも1つの症状が、前記サイロシビンの投与後、少なくとも1か月間緩和される、項目1~14のいずれか一項に記載の方法。
(項目18)
前記うつ病の少なくとも1つの症状が、前記サイロシビンの投与後、少なくとも3か月間緩和される、項目1~14のいずれか一項に記載の方法。
(項目19)
前記うつ病の少なくとも1つの症状が、前記サイロシビンの投与後、少なくとも12か月間緩和される、項目1~14のいずれか一項に記載の方法。
(項目20)
前記サイロシビンの投与後、前記うつ病の兆候または症状を低減するための他の治療は、前記対象に施されない、項目1~19のいずれか一項に記載の方法。
(項目21)
前記対象に、前記うつ病の兆候または症状を低減するための少なくとも1つの追加の治療剤を投与することをさらに含む、項目1~19のいずれか一項に記載の方法。
(項目22)
前記少なくとも1つの追加の治療剤が、選択的セロトニン再取り込み阻害剤、セロトニン及びノルエピネフリン再取り込み阻害剤、三環式抗うつ剤、四環式抗うつ剤、ドーパミン再取り込み阻害剤、5-HT
1A
受容体アンタゴニスト、5-HT
2
受容体アンタゴニスト、5-HT
3
受容体アンタゴニスト、モノアミン酸化酵素阻害剤、またはノルアドレナリン作動性アンタゴニストである、項目21に記載の方法。
(項目23)
前記少なくとも1つの追加の治療剤が、サイロシビンの投与前に投与される、項目21または22に記載の方法。
(項目24)
前記少なくとも1つの追加の治療剤が、サイロシビンの投与後に投与される、項目21または22に記載の方法。
(項目25)
前記少なくとも1つの追加の治療剤が、前記サイロシビンと同じ日に投与される、項目21または22に記載の方法。
(項目26)
前記対象が、以前にサイロシビンに曝露されていない、項目1~25のいずれか一項に記載の方法。
(項目27)
前記対象が、以前にサイロシビンに曝露されている、項目1~25のいずれか一項に記載の方法。
(項目28)
前記対象が、さらなる併存疾患または障害を有する、項目1~27のいずれか一項に記載の方法。
(項目29)
前記対象が、不安障害、強迫性障害、アルコール依存症、人格障害、心血管疾患、神経疾患、またはがんを有する、項目28に記載の方法。
(項目30)
前記神経疾患が、認知症、アルツハイマー病、またはパーキンソン病である、項目29に記載の方法。
(項目31)
前記対象におけるうつ病の少なくとも1つの兆候または症状の低減が、前記対象における1つ以上の併存疾患または障害を治療または予防する、項目28~30のいずれか一項に記載の方法。
(項目32)
前記対象が、哺乳動物である、項目1~31のいずれか一項に記載の方法。
(項目33)
前記対象が、ヒトである、項目32に記載の方法。
(項目34)
前記サイロシビンが、治療有効量の多形体Aの形態での高純度結晶性サイロシビンを含む剤形で投与され、前記結晶性サイロシビンが、少なくとも90重量%の多形体Aを含む、項目1~33のいずれかに記載の方法。
(項目35)
前記結晶性サイロシビンが、少なくとも95重量%の多形体Aを含む、項目34に記載の方法。
(項目36)
前記結晶性サイロシビンが、HPLCによって97%超の化学純度を有し、1%超の単一の不純物を有しない、項目34または35に記載の方法。
(項目37)
前記サイロシビンが、治療有効量の多形体Aの形態での高純度結晶性サイロシビンを含む剤形で投与され、前記結晶性サイロシビンが、HPLCによって97%超の化学純度を有し、1%超の単一の不純物を有しない、項目1~33のいずれか一項に記載の方法。
(項目38)
前記高純度結晶性サイロシビンが、少なくとも90重量%の多形体Aを含む、項目37に記載の方法。
(項目39)
前記高純度結晶性サイロシビンが、少なくとも95重量%の多形体Aを含む、項目38に記載の方法。
(項目40)
前記高純度結晶性サイロシビンが、(i)0.5w/w%未満の水含有量、または(ii)25℃~200℃のTGAサーモグラムにおける0.5w/w%未満の減量のいずれかを有することをさらに特徴とする、項目34~39のいずれか一項に記載の方法。
(項目41)
前記高純度結晶性サイロシビンが、145℃~155℃の第1の開始温度及び205℃~220℃の第2の開始温度を有するDSCサーモグラムにおける吸熱事象をさらに特徴とする、項目34~40のいずれか一項に記載の方法。
(項目42)
前記高純度結晶性サイロシビンが、以下のうちの1つ以上をさらに特徴とする、項目34~41のいずれか一項に記載の方法:(a)2w/w%以下の乾燥減量、(b)0.5w/w%以下の発火における残留物、(c)HPLCによって測定される95~103重量%のアッセイ(乾燥ベース)、(d)HRGCによって測定される、3000ppm以下のメタノール、5000ppmのエタノール、720ppmのTHF、及び890ppmのトルエンの残留溶媒含有量、(e)
31
P NMRによって測定される、1w/w%以下のリン酸含有量、ならびに(f)(i)1.5ppm以下のCd、(ii)1.5ppm以下のPb、(iii)4.5ppm以下のAs、(iv)9.0ppm以下のHg、(v)15ppm以下のCo、(vi)30ppm以下のV、(vii)60ppm以下のNi、(viii)165ppm以下のLi、及び(ix)30ppm以下のPdの誘導結合プラズマ質量分析(ICP-MS)元素分析。
(項目43)
前記高純度結晶性サイロシビンが、0.5%超の単一の不純物を有しない、項目34~42のいずれか一項に記載の方法。
(項目44)
前記剤形が、約5~40mgの前記高純度結晶性サイロシビンをさらに含む、項目34~43のいずれかに記載の方法。
(項目45)
前記剤形が、5mgの高純度結晶性サイロシビンを含む、項目44に記載の方法。
(項目46)
前記剤形が、約10mgの高純度結晶性サイロシビンを含む、項目44に記載の方法。
(項目47)
前記剤形が、約35mgの高純度結晶性サイロシビンを含む、項目44に記載の方法。
(項目48)
前記剤形が、ケイ化微結晶セルロースを含む、項目34~47のいずれか一項に記載の方法。
(項目49)
前記ケイ化微結晶セルロースが、約45~150ミクロンの粒径範囲を有する、項目48に記載の方法。
(項目50)
2つのケイ化微結晶セルロースバリアントの混合物をさらに含み、前記第1のバリアントが、約45~80ミクロンの粒径を有し、前記第2のバリアントが、約90~150ミクロンの粒径を有する、項目34~49のいずれか一項に記載の方法。
(項目51)
前記微結晶セルロースの約30%以下が、前記約45~80ミクロンの粒径を有する第1のバリアントであり、前記微結晶セルロースの約70%以上が、前記約90~150ミクロンの粒径を有する第2のバリアントである、項目50に記載の方法。
(項目52)
前記微結晶セルロースの約20%以下が、前記約45~80ミクロンの粒径を有する第1のバリアントであり、前記微結晶セルロースの約80%以上が、前記約90~150ミクロンの粒径を有する第2のバリアントである、項目50に記載の方法。
(項目53)
前記微結晶セルロースの約15%以下が、前記約45~80ミクロンの粒径を有する第1のバリアントであり、前記微結晶セルロースの約85%以上が、前記約90~150ミクロンの粒径を有する第2のバリアントである、項目50に記載の方法。
(項目54)
前記剤形が、多形体Aの形態での5mgの結晶性サイロシビン、12.5mgのSMCC 50、79.5mgのSMCC 90、1mgのグリコール酸ナトリウムデンプン、1mgのコロイド状二酸化ケイ素、及び1mgのステアリルフマル酸ナトリウムを含む、項目53に記載の方法。
(項目55)
前記剤形が、多形体Aの形態での1mgの結晶性サイロシビン、20.5mgのSMCC 50、75.5mgのSMCC 90、1mgのグリコール酸ナトリウムデンプン、1mgのコロイド状二酸化ケイ素、及び1mgのステアリルフマル酸ナトリウムを含む、項目53に記載の方法。
(項目56)
前記剤形が、経口剤形である、項目34~55のいずれか一項に記載の方法。
(項目57)
前記剤形が、カプセルである、項目56に記載の方法。
(項目58)
前記剤形が、錠剤である、項目56に記載の方法。
(項目59)
少なくとも1つの用量のサイロシビンが、前記対象に投与される、項目1~58のいずれか一項に記載の方法。
(項目60)
前記少なくとも1つの用量のサイロシビンが、約0.1mg~約100mgの範囲内である、項目59に記載の方法。
(項目61)
サイロシビンの前記用量が、約1mgである、項目60に記載の方法。
(項目62)
サイロシビンの前記用量が、約10mgである、項目60に記載の方法。
(項目63)
サイロシビンの前記用量が、約25mgである、項目60に記載の方法。
(項目64)
1回を超えるサイロシビンの用量が、前記対象に投与される、項目1~58のいずれか一項に記載の方法。
(項目65)
少なくとも2回の用量のサイロシビンが、前記対象に投与される、項目65に記載の方法。
(項目66)
前記サイロシビンが、1日1回投与される、項目64~65のいずれか一項に記載の方法。
(項目67)
前記サイロシビンが、1週間に少なくとも1回投与される、項目64~65のいずれか一項に記載の方法。
(項目68)
前記サイロシビンが、1週間に少なくとも2回投与される、項目64~65のいずれか一項に記載の方法。
(項目69)
前記サイロシビンが、1か月に少なくとも1回投与される、項目64~65のいずれか一項に記載の方法。
(項目70)
前記サイロシビンが、1か月に少なくとも2回投与される、項目64~65のいずれか一項に記載の方法。
(項目71)
前記サイロシビンが、3か月毎に少なくとも1回投与される、項目64~65のいずれか一項に記載の方法。
(項目72)
前記サイロシビンが、6か月毎に少なくとも1回投与される、項目64~65のいずれか一項に記載の方法。
(項目73)
前記サイロシビンが、12か月毎に少なくとも1回投与される、項目64~65のいずれか一項に記載の方法。
(項目74)
投与されるサイロシビンの各用量が、約0.1mg~約100mgの範囲内である、項目64~73のいずれか一項に記載の方法。
(項目75)
投与されるサイロシビンの各用量が、約1mgである、項目74に記載の方法。
(項目76)
投与されるサイロシビンの各用量が、約10mgである、項目74に記載の方法。
(項目77)
投与されるサイロシビンの各用量が、約25mgである、項目74に記載の方法。
(項目78)
前記サイロシビンが、経口、静脈内、筋肉内、非経口、局所、吸入、直腸、経粘膜、鼻腔内、頬、膣、くも膜下腔内、眼内、経皮、子宮内、リンパ内の経路のうちの1つによって、または直接組織もしくは臓器注射によって投与される、項目59~77のいずれか一項に記載の方法。
(項目79)
前記サイロシビンが、経口投与される、項目78に記載の方法。
(項目80)
前記対象が、前記サイロシビンの投与前、少なくとも1つの心理的支援セッションに参加する、項目1~79のいずれか一項に記載の方法。
(項目81)
前記対象が、前記サイロシビンの投与前、少なくとも3つの心理的支援セッションに参加する、項目80に記載の方法。
(項目82)
少なくとも1つの治療的意図が、前記心理的支援セッション中に話し合われる、項目80~81のいずれか一項に記載の方法。
(項目83)
自己主導型問診及び経験的処理が、前記心理的支援セッション中に実施される、項目80~82のいずれか一項に記載の方法。
(項目84)
前記対象が、前記サイロシビンの投与後、少なくとも1つの心理的支援セッションに参加する、項目80~83のいずれか一項に記載の方法。
(項目85)
前記対象が、前記サイロシビンの投与後、少なくとも3つの心理的支援セッションに参加する、項目84に記載の方法。
(項目86)
前記サイロシビンが、実質的に非臨床的な外観を有する部屋において前記対象に投与される、項目80~85のいずれか一項に記載の方法。
(項目87)
前記部屋が、柔らかい家具を備える、項目86に記載の方法。
(項目88)
前記部屋が、落ち着いた色を使用して装飾される、項目86に記載の方法。
(項目89)
前記部屋が、高解像度の音響システムを備える、項目86に記載の方法。
(項目90)
前記部屋が、ベッドまたはソファを備える、項目86~89のいずれか一項に記載の方法。
(項目91)
前記対象が、前記サイロシビンの投与後、約4~8時間、またはそのかなりの割合でベッドまたはソファに横たわる、項目90に記載の方法。
(項目92)
前記対象が、前記サイロシビンの投与後、約4~8時間、またはそのかなりの割合で音楽を聴く、項目86~91のいずれか一項に記載の方法。
(項目93)
前記対象が、前記サイロシビンの投与後、約4~8時間、またはそのかなりの割合でアイマスクを装着する、項目86~92のいずれか一項に記載の方法。
(項目94)
療法士が、前記サイロシビンの投与後、約4~8時間、前記対象に心理的支援を提供する、項目87~93のいずれか一項に記載の方法。
(項目95)
前記療法士が、前記対象を落ち着かせる及び/または前記対象の注意を集中させるために誘導イメージ療法及び/または呼吸運動を使用する、項目94に記載の方法。
(項目96)
前記療法士が、前記対象との安心させる物理的接触を提供する、項目94に記載の方法。
(項目97)
前記療法士が、前記対象の手、腕、または肩に触れる、項目96に記載の方法。
(項目98)
前記療法士が、前記対象に自己主導型問診及び経験的処理を実行することを奨励する、項目94に記載の方法。
(項目99)
前記療法士が、前記対象に少なくとも1つの治療的意図を思い出させる、項目94に記載の方法。
(項目100)
前記療法士が、以下のうちの1つ以上を行うように前記対象をカウンセリングする、項目94に記載の方法:(1)不安の感情を受け入れること、(2)経験を自然に展開させること、(3)経験に対する心理的抵抗を避けること、(4)リラックスすること、及び/または(5)前記対象自身の精神空間を探求すること。
(項目101)
前記療法士が、前記対象との会話を開始しない、項目94に記載の方法。
(項目102)
前記療法士が、前記対象が会話を開始する場合、前記対象に応答する、項目94に記載の方法。
(項目103)
前記心理的支援が、前記対象に遠隔的に提供される、項目80~102のいずれか一項に記載の方法。
(項目104)
前記心理的支援が、デジタルまたは電子システムを介して提供される、項目103に記載の方法。
(項目105)
前記デジタルまたは前記電子システムが、携帯電話アプリである、項目104に記載の方法。
(項目106)
前記デジタルまたは前記電子システムが、ウェブサイトである、項目105に記載の方法。
(項目107)
本特許請求の範囲に記載の方法。
(項目108)
本特許請求の範囲に記載の製剤。
(項目109)
本特許請求の範囲に記載の結晶性サイロシビン。
(項目110)
本特許請求の範囲に記載のように本特許請求の範囲に記載の結晶性サイロシビンを含む、薬学的剤形。
(項目111)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、以下の疾患、障害、または状態のうちの少なくとも1つを有する、前記方法:重篤気分調節障害、大うつ病性障害(MDD)、治療抵抗性うつ病、持続性抑うつ障害(気分変調症)、月経前不快気分障害、物質/薬剤誘発性抑うつ障害、分娩後うつ病、または別の医学的状態に起因する抑うつ障害、分離不安障害、選択的無言症、特定恐怖症、社会不安障害(社会恐怖症)、パニック障害、パニック発作、広場恐怖症、全般性不安障害、物質-薬剤誘発性不安障害、別の病態に起因する不安障害、身体症状障害、病気不安障害(心気症)、転換性障害(機能性神経症状障害)、虚偽性障害、心的外傷後ストレス障害(PTSD)、適応障害、急性苦痛障害、強迫性障害、身体醜形障害、ホーディング障害、抜毛癖(抜毛)障害、擦りむき(皮膚むしり)障害、物質/薬物誘発性強迫性及び関連障害、別の病態に起因する強迫性及び関連障害、物質関連障害、アルコール関連障害、***関連障害、幻覚剤関連障害、吸入剤関連障害、コカイン関連の障害、オピオイド関連障害、鎮静剤関連、睡眠剤関連、または抗不安剤関連障害、刺激剤関連障害、タバコ関連障害、非物質関連障害(ギャンブルまたはゲーム障害)、片頭痛、慢性群発性頭痛などの群発性頭痛、周期的嘔吐、緊張型頭痛、不全失語症、異食症、神経性拒食症、神経性過食症、過食性障害、反抗的行為障害、間欠性爆発性障害、行為障害、***的人格障害、精神病質、放火癖、または窃盗癖。
(項目112)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、以下の疾患、障害、または状態のうちの少なくとも1つを有する、前記方法:アルツハイマー病、レビー小体、外傷性脳損傷、プリオン病、HIV感染症、パーキンソン病、またはハンチントン病に起因する神経認知障害、脳震盪、慢性外傷性脳症(CTE)、言語障害、発話障害(音声障害)、小児期発症性流動性障害(吃音)、社会的(実用的)コミュニケーション障害、トゥレット障害、持続性(慢性)運動または声帯チック障害、既知の生理学的状態に起因する健忘障害、一過性脳虚血発作、脳梗塞、脳出血、進行性多核眼筋麻痺、または逆行性健忘。
(項目113)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、以下の疾患、障害、または状態のうちの少なくとも1つを有する、前記方法:自閉症スペクトラム障害または***的人格障害。
(項目114)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、以下の疾患、障害、または状態のうちの少なくとも1つを有する、前記方法:注意欠陥/多動性障害、その他の特定の注意欠陥/多動性障害、または特定されていない注意欠陥/多動性障害。
(項目115)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、以下の疾患、障害、または状態のうちの少なくとも1つを有する、前記方法:統合失調性(人格)障害、妄想性障害、統合失調症、または統合失調性感情障害。
(項目116)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、以下の疾患、障害、または状態のうちの少なくとも1つを有する、前記方法:女性の性的興味/性的興奮障害、男性の性的欲求低下障害、または過度の性的衝動。
(項目117)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、以下の疾患、障害、または状態のうちの少なくとも1つを有する、前記方法:双極性障害I型、双極性障害II型、または気分循環性障害。
(項目118)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、以下の疾患、障害、または状態のうちの少なくとも1つを有する、前記方法:不眠障害、過眠障害、ナルコレプシー、または原発性中枢性睡眠時無呼吸症、のうちの少なくとも1つを有する、前記方法。
(項目119)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、以下の疾患、障害、または状態のうちの少なくとも1つを有する、前記方法:統合失調症性人格障害、統合失調症型人格障害、***的人格障害、境界性人格障害、または強迫性人格障害。
(項目120)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、以下の疾患、障害、または状態のうちの少なくとも1つを有する、前記方法:加齢関連聴力損失または耳鳴。
(項目121)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、以下の疾患、障害、または状態のうちの少なくとも1つを有する、前記方法:多発性硬化症、脳神経障害、視神経脊髄炎、ベル麻痺、ギランバレー症候群、中枢神経系の脱髄性疾患、または慢性炎症性脱髄性多発神経炎。
(項目122)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、疼痛に苦しんでいる、前記方法。
(項目123)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、以下の疾患、障害、または状態のうちの少なくとも1つを有する、前記方法:脊髄症、外傷性脳損傷、知的障害、躁病、神経変性、性的倒錯障害、自殺行動障害、非自殺性自傷行為障害、持続性複雑死障害、胃腸管関連疾患、てんかん、鎌状赤血球病、ロックイン症候群、レストレスレッグス症候群、脳卒中、または筋萎縮性側索硬化症(ALS)。
(項目124)
対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、投与後、前記対象が、認知の改善を示す、前記方法。
(項目125)
前記認知の改善が、注意、エピソード記憶、作業記憶、空間記憶、社会的認知、実行機能、及び/または認知の柔軟性の改善である、項目124に記載の方法。
(項目126)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、治療抵抗性うつ病(TRD)を有する、前記方法。
(項目127)
治療を必要とする対象を治療する方法であって、前記対象に、治療有効用量のサイロシビンを投与することを含み、前記対象が、大うつ病性障害(MDD)を有する、前記方法。
(項目128)
前記対象が、哺乳動物である、項目111~127のいずれか一項に記載の方法。
(項目129)
前記対象が、ヒトである、項目18に記載の方法。
(項目130)
前記サイロシビンが、治療有効量の多形体Aの形態での高純度結晶性サイロシビンを含む剤形で投与され、前記結晶性サイロシビンが、少なくとも90重量%の多形体Aを含む、項目111~129のいずれかに記載の方法。
(項目131)
前記結晶性サイロシビンが、少なくとも95重量%の多形体Aを含む、項目130に記載の方法。
(項目132)
前記結晶性サイロシビンが、HPLCによって97%超の化学純度を有し、1%超の単一の不純物を有しない、項目130または131に記載の方法。
(項目133)
前記サイロシビンが、治療有効量の多形体Aの形態での高純度結晶性サイロシビンを含む剤形で投与され、前記結晶性サイロシビンが、HPLCによって97%超の化学純度を有し、1%超の単一の不純物を有しない、項目111~132のいずれかに記載の方法。
(項目134)
2つのケイ化微結晶セルロースバリアントの混合物をさらに含み、前記第1のバリアントが、約45~80ミクロンの粒径を有し、前記第2のバリアントが、約90~150ミクロンの粒径を有する、項目130~133のいずれかに記載の方法。
(項目135)
前記微結晶セルロースの約30%以下が、前記約45~80ミクロンの粒径を有する第1のバリアントであり、前記微結晶セルロースの約70%以上が、前記約90~150ミクロンの粒径を有する第2のバリアントである、項目24に記載の方法。
(項目136)
前記剤形が、経口剤形である、項目130~135のいずれか一項に記載の方法。
(項目137)
前記剤形が、カプセルである、項目136に記載の方法。
(項目138)
前記剤形が、錠剤である、項目136に記載の方法。
(項目139)
少なくとも1つの用量のサイロシビンが、前記対象に投与される、項目111~138のいずれか一項に記載の方法。
(項目140)
前記少なくとも1つの用量のサイロシビンが、約0.1mg~約100mgの範囲内である、項目139に記載の方法。
(項目141)
サイロシビンの前記用量が、約25mgである、項目140に記載の方法。
(項目142)
前記対象が、前記サイロシビンの投与前、少なくとも1つの心理的支援セッションに参加する、項目111~141のいずれか一項に記載の方法。
(項目143)
前記対象が、前記サイロシビンの投与後、少なくとも1つの心理的支援セッションに参加する、項目142に記載の方法。
(項目144)
療法士が、前記サイロシビンの投与後、約4~8時間、前記対象に心理的支援を提供する、項目142または143に記載の方法。
(項目145)
治療有効量の多形体Aの形態での高純度結晶性サイロシビンを含む剤形であって、前記結晶性サイロシビンが、少なくとも90重量%の多形体Aを含み、2つのケイ化微結晶セルロースバリアントの混合物をさらに含み、前記第1のバリアントが、約45~80ミクロンの粒径(SMCC 50)を有し、前記第2のバリアントが、約90~150ミクロンの粒径(SMCC 90)を有し、SMCC 50対SMCC 90の比率が、1:5~1:8の重量%である、前記剤形。
(項目146)
崩壊剤、流動促進剤、または滑沢剤をさらに含む、項目145に記載の剤形。
(項目147)
崩壊剤を含み、前記崩壊剤が、3%未満(重量%)、2%未満、または1%以下のデンプングリコール酸ナトリウムである、項目147に記載の剤形。
(項目148)
SMCC 50対SMCC 90の比率が、1:5~1:7、1:6~1:7、1:6~1:8、1.7~1.8、1:6、1:6.1、1:6.2、1:6.3、1:6.4、1:6.5、1:6.6、1.6.7、1:6.8、1.6.9、または1:7である、項目145~147のいずれか一項に記載の剤形。
(項目149)
5~40mgのサイロシビンを含む、項目145~147のいずれか一項に記載の剤形。
(項目150)
5mgのサイロシビン、SMCC 50及びSMCC 90(SMCC 50対SMCC 90の比率が、1:6.4である)、ならびに約0.5%~1.0%のデンプングリコール酸ナトリウムを含む、項目145に記載の剤形。
(項目151)
5mgのサイロシビン、SMCC 50及びSMCC 90(SMCC 50対SMCC 90の比率が、1:6.4である)、ならびに約0.5%のデンプングリコール酸ナトリウムを含む、項目145に記載の剤形。
(項目152)
10mgのサイロシビン、SMCC 50及びSMCC 90(SMCC 50対SMCC 90の比率が、1:6.4である)、ならびに約1%のデンプングリコール酸ナトリウムを含む、項目145に記載の剤形。
(項目153)
10mgのサイロシビン、SMCC 50及びSMCC 90(SMCC 50対SMCC 90の比率が、1:6.4である)、ならびに約0.5%~1.0%のデンプングリコール酸ナトリウムを含む、項目145に記載の剤形。
(項目154)
10mgのサイロシビン、SMCC 50及びSMCC 90(SMCC 50対SMCC 90の比率が、1:6.4である)、ならびに約0.5%のデンプングリコール酸ナトリウムを含む、項目145に記載の剤形。
(項目155)
25mgのサイロシビン、SMCC 50及びSMCC 90(SMCC 50対SMCC 90の比率が、1:6.4である)、ならびに約1%のデンプングリコール酸ナトリウムを含む、項目145に記載の剤形。
(項目156)
25mgのサイロシビン、SMCC 50及びSMCC 90(SMCC 50対SMCC 90の比率が、1:6.4である)、ならびに約0.5%~1.0%のデンプングリコール酸ナトリウムを含む、項目145に記載の剤形。
(項目157)
25mgのサイロシビン、SMCC 50及びSMCC 90(SMCC 50対SMCC 90の比率が、1:6.4である)、ならびに約0.5%のデンプングリコール酸ナトリウムを含む、項目145に記載の剤形。
(項目158)
5mgの結晶性サイロシビンA、12.5mgのSMCC 50、79.5mgのSMCC 90、1mgのグリコール酸ナトリウムデンプン、1mgのコロイド状二酸化ケイ素、及び1mgのステアリルフマル酸ナトリウムを含む、項目145に記載の剤形。
(項目159)
前記結晶性サイロシビンが、少なくとも95重量%の多形体Aを含む、項目145~158のいずれか一項に記載の剤形。
(項目160)
前記剤形が、経口剤形である、項目145~158のいずれか一項に記載の剤形。
(項目161)
前記剤形が、カプセルである、項目145~158のいずれか一項に記載の剤形。
(項目162)
前記剤形が、錠剤である、項目145~158のいずれか一項に記載の剤形。
The foregoing is an illustrative description of the invention and should not be construed as a limitation thereof. The invention is defined by the following claims, with equivalents of the claims to be included therein.
In certain embodiments, for example, the following are provided:
(Item 1)
A method of treating depression in a subject in need thereof, said method comprising administering to said subject an effective amount of psilocybin or an active metabolite thereof.
(Item 2)
The subject has major depressive disorder, atypical depression, bipolar disorder, catatonic depression, depressive disorder due to a medical condition, postpartum depression, premenstrual dysphoric disorder, or seasonal The method of item 1, having an affective disorder.
(Item 3)
3. The method of item 2, wherein the subject has major depressive disorder.
(Item 4)
3. The method of item 2, wherein the subject has bipolar disorder.
(Item 5)
5. The method of item 4, wherein the subject has bipolar I disorder.
(Item 6)
5. The method of item 4, wherein the subject has bipolar disorder type II.
(Item 7)
7. The method of any one of items 1-6, wherein the depression is refractory to treatment.
(Item 8)
8. The method of any one of items 1-7, wherein at least one sign or symptom of depression is reduced.
(Item 9)
said signs or symptoms of depression are depressed mood, decreased interest in activities, weight loss or gain, decreased or increased appetite, insomnia or hypersomnia, psychomotor agitation or retardation, fatigue or loss of energy; 9. The method of item 8, wherein feelings of worthlessness or excessive or inappropriate guilt, poor concentration or indecision, or suicidal ideation or behavior.
(Item 10)
10. The method of item 9, wherein the signs or symptoms of depression are measured according to diary assessment, clinician or caregiver assessment, clinical rating scales, or by functional MRI.
(Item 11)
The clinical depression rating scale includes the Brief Depressive Symptom Scale (QIDS)-16 Scale, QIDS-16 Daily Scale, Hamilton Depression Rating Scale, Beck Depression Inventory Scale, Montgomery-Asberg Depression Rating Scale, Clinical Global Impression Scale, 11. The method of item 10, which is the Zung Self-Rating Depression Scale, the Raskin Depression Rating Scale, and/or the Young Mania Rating Scale.
(Item 12)
The signs or symptoms of depression are assessed by Spielberger's Traits and Anxiety Inventory, Generalized Anxiety Disorder 7-Item Scale, Warwick-Edinburgh Mental Wellbeing Scale, Flourishing Scale, Snaith Hamilton's Anhedonia Pleasure Scale, Life Orientation Test, Meaning of Life Question Vote, Brief Resilience Scale, Nonfunctional Attitude Scale, 44-item Big Five Inventory, Peters 21-item Delusional Inventory, Test of Abnormal Self-Experiences, Contemplative Reaction Scale, Polar Bear Suppression Inventory, Barrett Impulsiveness Scale, Brief Experience Therapeutic Avoidance Questionnaire, Modified Tellegen Immersion Questionnaire, Scale for Assessing Therapeutic Relationships, Confidence/Expectation Questionnaire, Nature Connection Scale, Political Perspective Questionnaire, Social Connection Scale, Bech-Rafaelsen Mania the revised Santa Clara Concise Compassion Scale, the Appreciation Questionnaire, the Short Recommendation Scale, the Rosenberg Self-Esteem Scale, the Universality Subscale of the Mental Transcendence Scale, the Oxford Questionnaire on the Emotional Side Effects of Antidepressants, Lauks Affective Intensity Scale, Sexual Dysfunction Questionnaire, Brief Index of Female Sexual Function, Sexual Awareness Questionnaire, Barnes Akathisia Rating Scale, Occupational Productivity and Disability Questionnaire, Work and Social Adaptability Scale, Connectivity Questionnaire , Personality Standard Rating, Positive and Negative Syndrome Scale, Mastery Insight Scale, Self-Reflection and Insight Scale, Psychological Insight Scale, Metaphysical Belief Questionnaire, Spiritual Bypassing Scale, Adverse Early Childhood Experiences Questionnaire, Therapeutic Music Experiences Questionnaire, Setting Questionnaire, Musical Preoccupation Scale, Psychedelic Predictor Scale, Surrender Scale, EuroQOL-5 Dimensions-3 Level Scale, Columbia Suicide Severity Rating Scale, 11. The method of item 10, as measured using the Suicidal Idea Attribute Scale, or any combination thereof.
(Item 13)
11. The method of item 10, wherein said functional MRI measures the blood oxygen level dependent (BOLD) response of the amygdala.
(Item 14)
14. Method according to item 13, wherein the BOLD response is measured in a resting state, in response to an emotional face and/or music as a pleasurable stimulus.
(Item 15)
15. The method of any one of items 1-14, wherein at least one sign or symptom of depression is alleviated within 24 hours of administration of said psilocybin.
(Item 16)
15. The method of any one of items 1-14, wherein at least one symptom of depression is alleviated within one week of administration of said psilocybin.
(Item 17)
15. The method of any one of items 1-14, wherein at least one symptom of depression is alleviated for at least one month after administration of said psilocybin.
(Item 18)
15. The method of any one of items 1-14, wherein said at least one symptom of depression is alleviated for at least 3 months after administration of said psilocybin.
(Item 19)
15. The method of any one of items 1-14, wherein at least one symptom of depression is alleviated for at least 12 months after administration of said psilocybin.
(Item 20)
20. The method of any one of items 1-19, wherein no other treatment is administered to the subject to reduce the signs or symptoms of depression after administration of the psilocybin.
(Item 21)
20. The method of any one of items 1-19, further comprising administering to said subject at least one additional therapeutic agent for reducing said signs or symptoms of depression.
(Item 22)
the at least one additional therapeutic agent is a selective serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, a tricyclic antidepressant, a tetracyclic antidepressant, a dopamine reuptake inhibitor, 5-HT 1A 22. The method of item 21, wherein the receptor antagonist, 5-HT2 receptor antagonist, 5-HT3 receptor antagonist, monoamine oxidase inhibitor, or noradrenergic antagonist.
(Item 23)
23. The method of item 21 or 22, wherein said at least one additional therapeutic agent is administered prior to administration of psilocybin.
(Item 24)
23. The method of item 21 or 22, wherein said at least one additional therapeutic agent is administered after administration of psilocybin.
(Item 25)
23. The method of item 21 or 22, wherein said at least one additional therapeutic agent is administered on the same day as said psilocybin.
(Item 26)
26. The method of any one of items 1-25, wherein the subject has not been previously exposed to psilocybin.
(Item 27)
26. The method of any one of items 1-25, wherein the subject has previously been exposed to psilocybin.
(Item 28)
28. The method of any one of items 1-27, wherein said subject has an additional comorbidity or disorder.
(Item 29)
29. The method of item 28, wherein the subject has an anxiety disorder, obsessive-compulsive disorder, alcoholism, personality disorder, cardiovascular disease, neurological disease, or cancer.
(Item 30)
30. The method of item 29, wherein the neurological disease is dementia, Alzheimer's disease, or Parkinson's disease.
(Item 31)
31. The method of any one of items 28-30, wherein reduction of at least one sign or symptom of depression in said subject treats or prevents one or more co-morbidities or disorders in said subject.
(Item 32)
32. The method of any one of items 1-31, wherein the subject is a mammal.
(Item 33)
33. The method of item 32, wherein the subject is a human.
(Item 34)
of items 1-33, wherein said psilocybin is administered in a dosage form comprising a therapeutically effective amount of highly pure crystalline psilocybin in the form of polymorph A, said crystalline psilocybin comprising at least 90% by weight of polymorph A. Any method described.
(Item 35)
35. The method of item 34, wherein said crystalline psilocybin comprises at least 95% by weight of polymorph A.
(Item 36)
36. The method of item 34 or 35, wherein said crystalline psilocybin has a chemical purity of greater than 97% by HPLC and no single impurity greater than 1%.
(Item 37)
Said psilocybin is administered in a dosage form comprising a therapeutically effective amount of highly pure crystalline psilocybin in the form of polymorph A, said crystalline psilocybin having a chemical purity of greater than 97% by HPLC and a purity of greater than 1%. 34. The method of any one of items 1-33, which does not have a single impurity.
(Item 38)
38. The method of item 37, wherein said highly pure crystalline psilocybin comprises at least 90% by weight of polymorph A.
(Item 39)
39. The method of item 38, wherein said highly pure crystalline psilocybin comprises at least 95% by weight of polymorph A.
(Item 40)
wherein said high purity crystalline psilocybin has either (i) a water content of less than 0.5 w/w% or (ii) a weight loss of less than 0.5 w/w% in the TGA thermogram from 25°C to 200°C. 40. A method according to any one of items 34-39, further characterized in that it comprises:
(Item 41)
of items 34-40, wherein said high purity crystalline psilocybin is further characterized by an endothermic event in a DSC thermogram having a first onset temperature of 145°C to 155°C and a second onset temperature of 205°C to 220°C A method according to any one of paragraphs.
(Item 42)
42. The method of any one of items 34-41, wherein said highly pure crystalline psilocybin is further characterized by one or more of: (a) loss on drying of 2 w/w % or less, (b) (c) 95-103 wt% assay (dry basis) as determined by HPLC; (d) 3000 ppm or less methanol, 5000 ppm ethanol as determined by HRGC. , THF of 720 ppm, and toluene of 890 ppm; (e) phosphoric acid content of 1 w/w% or less, as measured by 31 P NMR; and (f) (i) Cd of 1.5 ppm or less . (ii) Pb up to 1.5 ppm, (iii) As up to 4.5 ppm, (iv) Hg up to 9.0 ppm, (v) Co up to 15 ppm, (vi) V up to 30 ppm, (vii) Inductively Coupled Plasma Mass Spectrometry (ICP-MS) elemental analysis for Ni ≤60 ppm, (viii) Li ≤165 ppm, and (ix) Pd ≤30 ppm.
(Item 43)
43. The method of any one of items 34-42, wherein said highly pure crystalline psilocybin does not have a single impurity greater than 0.5%.
(Item 44)
44. The method of any of items 34-43, wherein said dosage form further comprises about 5-40 mg of said high purity crystalline psilocybin.
(Item 45)
45. The method of item 44, wherein the dosage form comprises 5 mg of highly purified crystalline psilocybin.
(Item 46)
45. The method of item 44, wherein the dosage form comprises about 10 mg of highly purified crystalline psilocybin.
(Item 47)
45. The method of item 44, wherein the dosage form comprises about 35 mg of highly purified crystalline psilocybin.
(Item 48)
48. The method of any one of items 34-47, wherein the dosage form comprises silicified microcrystalline cellulose.
(Item 49)
49. The method of item 48, wherein the silicified microcrystalline cellulose has a particle size range of about 45-150 microns.
(Item 50)
Further comprising a mixture of two silicified microcrystalline cellulose variants, said first variant having a particle size of about 45-80 microns and said second variant having a particle size of about 90-150 microns. , items 34-49.
(Item 51)
about 30% or less of the microcrystalline cellulose is the first variant having a particle size of about 45-80 microns, and about 70% or more of the microcrystalline cellulose has a particle size of about 90-150 microns. 51. The method of item 50, which is the second variant comprising:
(Item 52)
about 20% or less of the microcrystalline cellulose is the first variant having a particle size of about 45-80 microns, and about 80% or more of the microcrystalline cellulose has a particle size of about 90-150 microns. 51. The method of item 50, which is the second variant comprising:
(Item 53)
About 15% or less of said microcrystalline cellulose is said first variant having a particle size of about 45-80 microns, and about 85% or more of said microcrystalline cellulose has a particle size of about 90-150 microns. 51. The method of item 50, which is the second variant comprising:
(Item 54)
The dosage form comprises 5 mg crystalline psilocybin in the form of Polymorph A, 12.5 mg SMCC 50, 79.5 mg SMCC 90, 1 mg sodium starch glycolate, 1 mg colloidal silicon dioxide, and 1 mg stearyl 54. The method of item 53, comprising sodium fumarate.
(Item 55)
The dosage form comprises 1 mg crystalline psilocybin in the form of Polymorph A, 20.5 mg SMCC 50, 75.5 mg SMCC 90, 1 mg sodium starch glycolate, 1 mg colloidal silicon dioxide, and 1 mg stearyl 54. The method of item 53, comprising sodium fumarate.
(Item 56)
56. The method of any one of items 34-55, wherein said dosage form is an oral dosage form.
(Item 57)
57. The method of item 56, wherein the dosage form is a capsule.
(Item 58)
57. The method of item 56, wherein the dosage form is a tablet.
(Item 59)
59. The method of any one of items 1-58, wherein at least one dose of psilocybin is administered to said subject.
(Item 60)
60. The method of item 59, wherein said at least one dose of psilocybin is in the range of about 0.1 mg to about 100 mg.
(Item 61)
61. The method of item 60, wherein said dose of psilocybin is about 1 mg.
(Item 62)
61. The method of item 60, wherein said dose of psilocybin is about 10 mg.
(Item 63)
61. The method of item 60, wherein said dose of psilocybin is about 25 mg.
(Item 64)
59. The method of any one of items 1-58, wherein more than one dose of psilocybin is administered to said subject.
(Item 65)
66. The method of item 65, wherein at least two doses of psilocybin are administered to the subject.
(Item 66)
66. The method of any one of items 64-65, wherein said psilocybin is administered once daily.
(Item 67)
66. The method of any one of items 64-65, wherein said psilocybin is administered at least once a week.
(Item 68)
66. The method of any one of items 64-65, wherein said psilocybin is administered at least twice a week.
(Item 69)
66. The method of any one of items 64-65, wherein said psilocybin is administered at least once a month.
(Item 70)
66. The method of any one of items 64-65, wherein said psilocybin is administered at least twice a month.
(Item 71)
66. The method of any one of items 64-65, wherein said psilocybin is administered at least once every three months.
(Item 72)
66. The method of any one of items 64-65, wherein said psilocybin is administered at least once every six months.
(Item 73)
66. The method of any one of items 64-65, wherein said psilocybin is administered at least once every 12 months.
(Item 74)
74. The method of any one of items 64-73, wherein each dose of psilocybin administered is within the range of about 0.1 mg to about 100 mg.
(Item 75)
75. The method of item 74, wherein each dose of psilocybin administered is about 1 mg.
(Item 76)
75. The method of item 74, wherein each dose of psilocybin administered is about 10 mg.
(Item 77)
75. The method of item 74, wherein each dose of psilocybin administered is about 25 mg.
(Item 78)
wherein said psilocybin is administered via oral, intravenous, intramuscular, parenteral, topical, inhalation, rectal, transmucosal, intranasal, buccal, vaginal, intrathecal, intraocular, transdermal, intrauterine, intralymphatic routes; or by direct tissue or organ injection.
(Item 79)
79. The method of item 78, wherein said psilocybin is administered orally.
(Item 80)
80. The method of any one of items 1-79, wherein the subject participates in at least one psychological support session prior to administration of the psilocybin.
(Item 81)
81. The method of item 80, wherein the subject participates in at least three psychological support sessions prior to administration of the psilocybin.
(Item 82)
82. The method of any one of items 80-81, wherein at least one therapeutic intent is discussed during said psychological support session.
(Item 83)
83. The method of any one of items 80-82, wherein self-directed inquiry and empirical treatment are performed during said psychological support session.
(Item 84)
84. The method of any one of items 80-83, wherein the subject participates in at least one psychological support session after administration of the psilocybin.
(Item 85)
85. The method of item 84, wherein the subject participates in at least three psychological support sessions after administration of the psilocybin.
(Item 86)
86. The method of any one of items 80-85, wherein said psilocybin is administered to said subject in a room having a substantially non-clinical appearance.
(Item 87)
87. Method according to item 86, wherein the room comprises soft furniture.
(Item 88)
87. Method according to item 86, wherein the room is decorated using calm colors.
(Item 89)
87. Method according to item 86, wherein the room comprises a high definition sound system.
(Item 90)
89. Method according to any one of items 86-89, wherein said room comprises a bed or a sofa.
(Item 91)
91. The method of item 90, wherein the subject lies on a bed or sofa for about 4-8 hours, or a substantial percentage thereof, after administration of the psilocybin.
(Item 92)
92. The method of any one of items 86-91, wherein the subject listens to music for about 4-8 hours, or a substantial percentage thereof, after administration of the psilocybin.
(Item 93)
93. The method of any one of items 86-92, wherein the subject wears an eye mask for about 4-8 hours, or a substantial percentage thereof, after administration of the psilocybin.
(Item 94)
94. The method of any one of items 87-93, wherein a therapist provides psychological support to the subject for about 4-8 hours after administration of the psilocybin.
(Item 95)
95. Method according to item 94, wherein the therapist uses guided imagery and/or respiratory exercises to calm the subject and/or focus the subject's attention.
(Item 96)
95. The method of item 94, wherein the therapist provides reassuring physical contact with the subject.
(Item 97)
97. The method of item 96, wherein the therapist touches the subject's hand, arm, or shoulder.
(Item 98)
95. The method of item 94, wherein the therapist encourages the subject to perform a self-directed inquiry and empirical treatment.
(Item 99)
95. The method of item 94, wherein the therapist reminds the subject of at least one therapeutic intent.
(Item 100)
95. The method of item 94, wherein the therapist counsels the subject to do one or more of the following: (1) accepting feelings of anxiety; (2) allowing the experience to unfold naturally; (3) avoiding psychological resistance to the experience; (4) relaxing; and/or (5) exploring the subject's own mental space.
(Item 101)
95. The method of item 94, wherein said therapist does not initiate a conversation with said subject.
(Item 102)
95. The method of item 94, wherein the therapist responds to the subject if the subject initiates a conversation.
(Item 103)
103. The method of any one of items 80-102, wherein the psychological support is provided to the subject remotely.
(Item 104)
104. The method of item 103, wherein the psychological support is provided via a digital or electronic system.
(Item 105)
104. Method according to item 104, wherein said digital or said electronic system is a mobile phone app.
(Item 106)
106. The method of item 105, wherein the digital or electronic system is a website.
(Item 107)
A method according to the present claims.
(Item 108)
A formulation according to the present claims.
(Item 109)
Crystalline psilocybin according to the claims.
(Item 110)
A pharmaceutical dosage form comprising crystalline psilocybin as claimed in this claim.
(Item 111)
A method of treating a subject in need thereof comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having at least one of the following diseases, disorders or conditions: , said methods: severe mood dysregulation disorder, major depressive disorder (MDD), treatment-resistant depression, persistent depressive disorder (dysthymia), premenstrual dysphoric disorder, substance/drug-induced depressive disorder, childbirth Post-depression or depressive disorder attributed to another medical condition, separation anxiety disorder, selective mutism, specific phobia, social anxiety disorder (social phobia), panic disorder, panic attacks, agoraphobia, generalized Anxiety disorders, substance-drug induced anxiety disorders, anxiety disorders attributed to other conditions, somatic symptom disorders, illness anxiety disorders (hypochondriasis), conversion disorders (functional neurosymptom disorders), factitious disorders, psychosocial Post-traumatic stress disorder (PTSD), adjustment disorder, acute distress disorder, obsessive-compulsive disorder, body dysmorphic disorder, hoarding disorder, trichotillomania (hair-pulling) disorder, scraping (skin picking) disorder, substance/drug-induced obsessive-compulsive and related disorders, obsessive-compulsive and related disorders due to another condition, substance-related disorders, alcohol-related disorders, cannabis-related disorders, hallucinogen-related disorders, inhalant-related disorders, ***e-related disorders, opioid-related disorders, sedative-related disorders , sedative-related or anxiolytic-related disorders, stimulant-related disorders, tobacco-related disorders, non-substance-related disorders (gambling or gaming disorders), migraines, cluster headaches such as chronic cluster headaches, periodic vomiting, nervousness type headache, incomplete aphasia, pica, anorexia nervosa, bulimia nervosa, bulimia nervosa, oppositional conduct disorder, intermittent explosive disorder, conduct disorder, antisocial personality disorder, psychopathy, pyromania, or Theft.
(Item 112)
A method of treating a subject in need thereof comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having at least one of the following diseases, disorders or conditions: , said method: neurocognitive impairment due to Alzheimer's disease, Lewy bodies, traumatic brain injury, prion disease, HIV infection, Parkinson's disease, or Huntington's disease, concussion, chronic traumatic encephalopathy (CTE), speech impairment, speech Disorders (speech disorders), childhood-onset fluidity disorders (stuttering), social (practical) communication disorders, Tourette's disorders, persistent (chronic) movement or vocal tic disorders, amnestic disorders attributed to known physiological conditions , transient ischemic attack, cerebral infarction, cerebral hemorrhage, progressive polynuclear ophthalmoplegia, or retrograde amnesia.
(Item 113)
A method of treating a subject in need thereof comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having at least one of the following diseases, disorders or conditions: , said method: Autism Spectrum Disorder or Antisocial Personality Disorder.
(Item 114)
A method of treating a subject in need thereof comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having at least one of the following diseases, disorders or conditions: , said method: attention-deficit/hyperactivity disorder, other specified attention-deficit/hyperactivity disorder, or unspecified attention-deficit/hyperactivity disorder.
(Item 115)
A method of treating a subject in need thereof comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having at least one of the following diseases, disorders or conditions: , said method: schizotypal (personality) disorder, delusional disorder, schizophrenia, or schizoaffective disorder.
(Item 116)
A method of treating a subject in need thereof comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having at least one of the following diseases, disorders or conditions: , said method: female sexual interest/sexual arousal disorder, male hypoactive sexual desire disorder, or excessive sexual urge.
(Item 117)
A method of treating a subject in need thereof comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having at least one of the following diseases, disorders or conditions: , said method: bipolar disorder type I, bipolar disorder type II, or cyclothymic disorder.
(Item 118)
A method of treating a subject in need thereof comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having at least one of the following diseases, disorders or conditions: , said method: having at least one of: an insomnia disorder, a hypersomnia disorder, narcolepsy, or primary central sleep apnea.
(Item 119)
A method of treating a subject in need thereof comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having at least one of the following diseases, disorders or conditions: , said method: schizophrenic personality disorder, schizotypal personality disorder, antisocial personality disorder, borderline personality disorder, or obsessive-compulsive personality disorder.
(Item 120)
A method of treating a subject in need thereof comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having at least one of the following diseases, disorders or conditions: , said method: age-related hearing loss or tinnitus.
(Item 121)
A method of treating a subject in need thereof comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having at least one of the following diseases, disorders or conditions: , said method: multiple sclerosis, cranial neuropathy, neuromyelitis optica, Bell's palsy, Guillain-Barre syndrome, demyelinating diseases of the central nervous system, or chronic inflammatory demyelinating polyneuropathy.
(Item 122)
A method of treating a subject in need thereof, said method comprising administering to said subject a therapeutically effective dose of psilocybin, said subject suffering from pain.
(Item 123)
A method of treating a subject in need thereof comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having at least one of the following diseases, disorders or conditions: , said methods: myelopathy, traumatic brain injury, intellectual disability, mania, neurodegeneration, paraphilia disorder, suicidal behavior disorder, non-suicidal self-harm disorder, persistent complicated death disorder, gastrointestinal related disease, epilepsy , sickle cell disease, lock-in syndrome, restless legs syndrome, stroke, or amyotrophic lateral sclerosis (ALS).
(Item 124)
A method of treating a subject, said method comprising administering to said subject a therapeutically effective dose of psilocybin, wherein said subject exhibits improved cognition after administration.
(Item 125)
125. The method of item 124, wherein said improvement in cognition is improvement in attention, episodic memory, working memory, spatial memory, social cognition, executive function, and/or cognitive flexibility.
(Item 126)
A method of treating a subject in need thereof, said method comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having treatment-resistant depression (TRD).
(Item 127)
A method of treating a subject in need thereof, said method comprising administering to said subject a therapeutically effective dose of psilocybin, said subject having Major Depressive Disorder (MDD).
(Item 128)
The method of any one of items 111-127, wherein said subject is a mammal.
(Item 129)
19. The method of item 18, wherein the subject is human.
(Item 130)
of items 111 to 129, wherein said psilocybin is administered in a dosage form comprising a therapeutically effective amount of highly pure crystalline psilocybin in the form of polymorph A, said crystalline psilocybin comprising at least 90% by weight of polymorph A. Any method described.
(Item 131)
131. The method of item 130, wherein said crystalline psilocybin comprises at least 95% by weight of polymorph A.
(Item 132)
132. The method of item 130 or 131, wherein said crystalline psilocybin has a chemical purity of greater than 97% by HPLC and no single impurity greater than 1%.
(Item 133)
Said psilocybin is administered in a dosage form comprising a therapeutically effective amount of highly pure crystalline psilocybin in the form of polymorph A, said crystalline psilocybin having a chemical purity of greater than 97% by HPLC and a purity of greater than 1%. 133. The method of any of items 111-132, which does not have a single impurity.
(Item 134)
Further comprising a mixture of two silicified microcrystalline cellulose variants, said first variant having a particle size of about 45-80 microns and said second variant having a particle size of about 90-150 microns. , items 130-133.
(Item 135)
about 30% or less of the microcrystalline cellulose is the first variant having a particle size of about 45-80 microns, and about 70% or more of the microcrystalline cellulose has a particle size of about 90-150 microns. 25. The method of item 24, which is a second variant comprising:
(Item 136)
136. The method of any one of items 130-135, wherein said dosage form is an oral dosage form.
(Item 137)
137. The method of item 136, wherein said dosage form is a capsule.
(Item 138)
137. The method of item 136, wherein said dosage form is a tablet.
(Item 139)
The method of any one of items 111-138, wherein at least one dose of psilocybin is administered to said subject.
(Item 140)
140. The method of item 139, wherein said at least one dose of psilocybin is in the range of about 0.1 mg to about 100 mg.
(Item 141)
141. The method of item 140, wherein said dose of psilocybin is about 25 mg.
(Item 142)
142. The method of any one of items 111-141, wherein the subject participates in at least one psychological support session prior to administration of the psilocybin.
(Item 143)
143. The method of item 142, wherein the subject participates in at least one psychological support session after administration of the psilocybin.
(Item 144)
144. The method of paragraphs 142 or 143, wherein a therapist provides psychological support to the subject for about 4-8 hours after administration of the psilocybin.
(Item 145)
1. A dosage form comprising a therapeutically effective amount of highly pure crystalline psilocybin in the form of polymorph A, said crystalline psilocybin comprising at least 90% by weight of polymorph A and comprising two silicified microcrystalline cellulose variants. further comprising a mixture, wherein the first variant has a particle size of about 45-80 microns (SMCC 50) and the second variant has a particle size of about 90-150 microns (SMCC 90) , the ratio of SMCC 50 to SMCC 90 is from 1:5 to 1:8 weight percent.
(Item 146)
146. The dosage form of item 145, further comprising a disintegrant, glidant, or lubricant.
(Item 147)
148. The dosage form of item 147, comprising a disintegrant, wherein the disintegrant is less than 3% (by weight), less than 2%, or less than 1% sodium starch glycolate.
(Item 148)
SMCC 50 to SMCC 90 ratio of 1:5 to 1:7, 1:6 to 1:7, 1:6 to 1:8, 1.7 to 1.8, 1:6, 1:6.1 , 1:6.2, 1:6.3, 1:6.4, 1:6.5, 1:6.6, 1.6.7, 1:6.8, 1.6.9, or Dosage form according to any one of items 145-147, which is 1:7.
(Item 149)
The dosage form of any one of items 145-147, comprising 5-40 mg of psilocybin.
(Item 150)
5 mg of psilocybin, SMCC 50 and SMCC 90 (the ratio of SMCC 50 to SMCC 90 is 1:6.4), and about 0.5% to 1.0% sodium starch glycolate, in item 145 Dosage form as described.
(Item 151)
146. The dosage form of item 145, comprising 5 mg of psilocybin, SMCC 50 and SMCC 90 (the ratio of SMCC 50 to SMCC 90 is 1:6.4), and about 0.5% sodium starch glycolate.
(Item 152)
146. The dosage form of item 145, comprising 10 mg of psilocybin, SMCC 50 and SMCC 90 (the ratio of SMCC 50 to SMCC 90 is 1:6.4), and about 1% sodium starch glycolate.
(Item 153)
Item 145, containing 10 mg of psilocybin, SMCC 50 and SMCC 90 (the ratio of SMCC 50 to SMCC 90 is 1:6.4), and about 0.5% to 1.0% sodium starch glycolate Dosage form as described.
(Item 154)
146. The dosage form of item 145, comprising 10 mg of psilocybin, SMCC 50 and SMCC 90 (the ratio of SMCC 50 to SMCC 90 is 1:6.4), and about 0.5% sodium starch glycolate.
(Item 155)
146. The dosage form of item 145, comprising 25 mg of psilocybin, SMCC 50 and SMCC 90 (the ratio of SMCC 50 to SMCC 90 is 1:6.4), and about 1% sodium starch glycolate.
(Item 156)
Item 145, containing 25 mg of psilocybin, SMCC 50 and SMCC 90 (the ratio of SMCC 50 to SMCC 90 is 1:6.4), and about 0.5% to 1.0% sodium starch glycolate Dosage form as described.
(Item 157)
146. The dosage form of item 145, comprising 25 mg of psilocybin, SMCC 50 and SMCC 90 (the ratio of SMCC 50 to SMCC 90 is 1:6.4), and about 0.5% sodium starch glycolate.
(Item 158)
146. The composition of claim 145, comprising 5 mg crystalline psilocybin A, 12.5 mg SMCC 50, 79.5 mg SMCC 90, 1 mg sodium starch glycolate, 1 mg colloidal silicon dioxide, and 1 mg sodium stearyl fumarate. dosage form.
(Item 159)
159. The dosage form of any one of items 145-158, wherein said crystalline psilocybin comprises at least 95% by weight of polymorph A.
(Item 160)
The dosage form of any one of items 145-158, wherein said dosage form is an oral dosage form.
(Item 161)
The dosage form of any one of items 145-158, wherein said dosage form is a capsule.
(Item 162)
Dosage form according to any one of items 145-158, wherein said dosage form is a tablet.
Claims (110)
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