1/2-MC4R 遺伝子型と小児用抗精神病薬による体重増加
2016年1月6日 更新者:Anil K. Malhotra、Northwell Health
12 週間のランダム化非盲検試験を実施し、13 ~ 18 歳の小児および青年を対象に、通常治療 (UC) の抗精神病薬治療 (アリピプラゾール、クエチアピン、リスペリドン) とジプラシドン (ZIP) を比較します。
患者は、生涯で 10 日以下の抗精神病薬にさらされており、FDA が抗精神病薬の使用を指示している小児精神障害、すなわち、双極性躁病、統合失調症スペクトラム障害、および自閉症に関連する過敏性に対する抗精神病治療が臨床的に必要とされています。
さらに、重度の気分調節障害 (SMD) の研究診断基準を満たす若者も含まれます。
無作為化は、MC4R遺伝子型に基づいて、抗精神病薬による体重増加の遺伝的リスクが高いか低いかによって層別化され、主要な結果は、2つの遺伝子型グループのそれぞれにおけるZIPおよびUC抗精神病治療の間のベースラインからエンドポイントまでの体重変化です。
以下に詳述するように、他の代謝および心臓の安全性パラメーターも測定され、各遺伝子型グループの治療間で比較されます。
調査の概要
状態
終了しました
研究の種類
介入
入学 (実際)
14
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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New York
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Glen Oaks、New York、アメリカ、11004
- Zucker Hillside Hospital, Psychiatry Research
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
13年~18年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
包含基準:
- 13~18歳
- 英語を話す
- それぞれの小児または成人の年齢グループの少なくとも 1 つの薬剤に対する SGA 使用の FDA 適応がある DSM 診断。 具体的には、早発性統合失調症スペクトラム障害の一次 DSM-IV 診断。双極 I 障害マニア (および BP-NOS); Leibenluftらによると、自閉症スペクトラム障害に関連する過敏性、および重度の気分調節障害(SMD)。 (2011) ABC-過敏性スコア >/=18 性的に活発な少女は、2 つの効果的な避妊法を使用するか禁欲することに同意する必要があります。
- -参加者には、研究に参加する前に少なくとも6か月間子供をよく知っている主な世話人がいます 主な世話人は研究の予定に参加することができます
- -治験責任医師の臨床的判断に従って、プロトコルのすべての側面に参加する子供の能力。
除外基準:
- 体重に影響を与える主要な神経学的または医学的疾患 (例: 不安定な甲状腺疾患)、禁止されている全身投薬 (例: 真性糖尿病 [インスリン]、慢性腎不全 [ステロイド]) が必要。 -スクリーニング中の2回の空腹時血糖> 125 mg / dL
- 体重を著しく変化させる薬(現在処方されている向精神薬を除く)
- BP-I または BP-NOS 患者では、少なくとも 2 週間は抗うつ薬を使用できません
- 食欲不振または神経性過食症のDSM-IV診断
- -過去1か月以内の薬物依存症(タバコ依存以外)のDSM-IV診断
- 初期の尿毒性スクリーニングとフォローアップスクリーニングは、違法物質の継続的な使用を示しています
- ZIPまたはUC抗精神病薬に対する過敏症
- 妊娠中、授乳中、または避妊要件を順守したくない
- スクリーニングまたはベースライン QTc > 450 ミリ秒
- IQ < 55
- 自己または他者に対する重大な危険性
- ソーシャルサービスの介入の新しい部門を必要とする進行中または以前に開示されていない児童虐待。
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:ジプラシドン
(20-160mg/日、入札) 12 週間
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ZIP へのランダム割り当て (20-160mg/日、入札投与)
他の名前:
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アクティブコンパレータ:アリピプラゾール、クエチアピン、リスペリドン
アリピプラゾール(2~30mg/日)、クエチアピン(25~800mg/日)またはリスペリドン(0.1~8mg/日)を12週間
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通常のケア抗精神病薬への無作為割付け
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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体重変化
時間枠:ベースラインから12週目まで
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ベースラインから12週目まで
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二次結果の測定
結果測定 |
時間枠 |
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ベースライン体重と比較した体重変化率
時間枠:ベースラインから12週目まで
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ベースラインから12週目まで
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BMI Z スコア
時間枠:ベースラインから12週目まで
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ベースラインから12週目まで
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BMIパーセンタイル
時間枠:ベースラインから12週目まで
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ベースラインから12週目まで
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年7月1日
一次修了 (実際)
2014年4月1日
研究の完了 (実際)
2014年4月1日
試験登録日
最初に提出
2013年4月29日
QC基準を満たした最初の提出物
2013年4月30日
最初の投稿 (見積もり)
2013年5月1日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年2月5日
QC基準を満たした最後の更新が送信されました
2016年1月6日
最終確認日
2016年1月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 12-403A
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