統合失調症の治療効果における神経細胞新生の関与に関する研究

Material type: 文書・図像類

Author: 三辺, 義雄ほか

Publisher: 金沢大学医薬保健研究域医学系

Publication date: 2008-05

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Note (General)：: 【目的】統合失調症の陰性症状、認知機能障害対するD1/D2受容体作動薬であるpergolideの効果を二重盲検比較試験で検討した。【方法】7病院において倫理委員会の承認を得た上で被験者に研究の内容を文書および口頭で説明し、文書での同意を得た。臨床試験はGCPならびにヘルシンキ宣言を遵守した上で行った...

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https://kaken.nii.ac.jp/search/?qm=60181947

https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-18390320/

https://kaken.nii.ac.jp/report/KAKENHI-PROJECT-18390320/183903202007kenkyu_seika_hokoku_gaiyo/

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Material Type: 文書・図像類
Title: 統合失調症の治療効果における神経細胞新生の関与に関する研究
Author/Editor: 三辺, 義雄
Minabe, Yoshio
Author Heading: 三辺, 義雄
Minabe, Yoshio
Publication, Distribution, etc.: 金沢大学医薬保健研究域医学系
Publication Date: 2008-05
Publication Date (W3CDTF): 2008-05
Alternative Title: Role of neurogenesis in the treatment of schizophrenia
Periodical title: 平成19(2007)年度科学研究費補助金基盤研究(B) 研究成果報告書 = 2007 Fiscal Year Final Research Report
No. or year of volume/issue: 2006-2007
Volume: 2006-2007
Pages: 5p.-
Text Language Code: jpn
Subject Heading: 統合失調症
MRS
認知機能
神経新生
ペルゴライド
二重盲検法
海馬
線条体
Schizophrenia
coeinitive function
neurogenesis
perogride
double-blind method
hippocampus
striatum
Target Audience: 一般
Note (General): 【目的】統合失調症の陰性症状、認知機能障害対するD1/D2受容体作動薬であるpergolideの効果を二重盲検比較試験で検討した。【方法】7病院において倫理委員会の承認を得た上で被験者に研究の内容を文書および口頭で説明し、文書での同意を得た。臨床試験はGCPならびにヘルシンキ宣言を遵守した上で行った。選択基準は1)年齢18〜50歳の統合失調症患者、2)risperidoneを2〜6mgの一定用量で8週間以上服用中、3)陽性および陰性症状評価尺度(PANSS)の陰性症状評価尺度が15点以上、4)試験開始前4週間におけるPANSSの点数の変動が20%以内で症状が安定している者である。除外基準は1)認知機能に影響を与えると考えられる既往歴および薬物治療を受けている、2)他の精神疾患の既往歴を持つ者である。被験者に無作為にpergolideまたはプラセボを割り付けた上で8週間で投与を受ける。pergolideは開始時に250μgで1週間投与し、2週目より750μgに増量し、合計8週間の投与した。精神症状の評価にはPANSS、社会機能の評価にはクオリティ・オブ・ライフ評価尺度(QLS)を用いた。錐体外路症状、アカシジア、ディスキネジアの評価はSimpson-Angus Rating Scale for Extrapyramidal Symptoms、 the Barnes Akathisia Scale、 and the Abnormal Involuntary Movement Scaleを用いた。病前の推定知能指数は日本語版NART(JART)を、現在の知能指数はWAIS-R短縮版を使用して測定した。認知機能の評価は神経心理学検査バッテリー(実行機能、空間作動記憶、持続的注意、言語記憶、言語性作動記憶、言語流暢性)を用いた。【結果】pergolide群13名、プラセボ群13名中、22名の被験者が全てのプロトコルを完了した。pergolide群とプラセボ群との間で、性別の割合、年齢、教育年齢、発症年齢、罹病期間、risperidoneの用量、試験開始時でのPANSSのスコアのいずれも差はなかった。試験薬と時間の関連性について二元配置分散分析を用いた解析で、PANSSの総スコア、陽性症状スコア、陰性症状スコア、QLSスコア、神経心理学的検査のいずれに評価項目においても、pergolide群とプラセボ群の間に有意差は見られなかった。
Method. Patients were included in the study if they: 1) were age 18-50 years, met the DSM-IV criteria for schizophrenia as assessed with the Structured Clinical Interview for DSM-IV, Research Version (SCID-RV); 2)were treated with a stable-dose of risperidone, raging 2 to 6mg, for more than 8 weeks; 3) had a score 〓15 on negative subscale items in Positive and Negative Syndrome Scale (PANSS), 4)had a minimum period of symptom stability, defined as no more than 20% change on consecutive ratings on PANSS for at lease 4 weeks. Subjects entered a 8-weeks, double-blind treatment phase during which they were randomly assigned to receive either pergolide or placebo, which was added to risperidone treatment. Pergolide was started at a daily dose of 250 μg for I week and increased to 750 μg from the second week, continuing for total of 8 weeks. The study medication and placebo were provided in identically appearing capsules. The PANSS was used to assess the severity of psychiatric symptoms, and the Quality of Life Scale (QLS) abbreviated version was used to measure general social functioning. Extrapyramidal symptoms, akathisia, and dyskinesia, were evaluated by the Simpson-Angus Rating Scale for Extrapyramidal Symptoms, the Barnes Akathisia Scale, and the Abnormal Involuntary Movement Scale. Estimates of premorbid and current intellectual functions were made by Japanese version of National Adult Reading Test(JART)and short form of Wechsler Adult Intelligence Scale-Revised(WAIS-R). Patients were tested on a comprehensive neuropsychological test battery: executive function, spatial working memory, sustained attention, verbal memory, verbal working memory, verbal fluency. Premorbid and current intellectual functions were measured at the baseline. Results. Twenty-six subjects were randomized to either pergolide or placebo (13 pergolide, 13 placebo; mean age t SD, 33.9 t 5.5 in pergolide, 37.2 ± 8.4 in placebo). Twenty-two subjects completed the entire protocol. No significant differences were noted between the PANSS total, positive scale, and negative scale scores between groups at baseline. Repeated-measures ANOVA revealed no significant differences between pergolide and placebo treatment groups during 8 weeks of the study with respect to PANSS total, PANSS positive, PANSS negative, and QLS scores. There were no statistically significant differences in change(from baseline to week 8)on any of the cognitive measures between the placebo and pergolide treated groups.
研究課題/領域番号:18390320, 研究期間(年度):2006-2007
出典：「統合失調症の治療効果における神経細胞新生の関与に関する研究」研究成果報告書　課題番号18390320 (KAKEN：科学研究費助成事業データベース（国立情報学研究所）)　　　本文データは著者版報告書より作成
DOI: 10.24517/00051184
Access Restrictions: 限定公開
Related Material: https://kaken.nii.ac.jp/search/?qm=60181947
https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-18390320/
https://kaken.nii.ac.jp/report/KAKENHI-PROJECT-18390320/183903202007kenkyu_seika_hokoku_gaiyo/
Data Provider (Database): 国立情報学研究所 : 学術機関リポジトリデータベース（IRDB）（機関リポジトリ）
https://irdb.nii.ac.jp
Original Data Provider (Database): 金沢大学 : 金沢大学学術情報リポジトリKURA