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Effect of Single Dose Intranasal Insulin On Cognitive Function

2013年2月12日 更新者：Xiaoduo Fan、University of Massachusetts, Worcester

Effect of Single Dose Intranasal Insulin on Cognitive Function in Patients With Schizophrenia

The purpose of the study is to find out how a small dose of insulin might affect memory, the ability to concentrate, and improve your daily functioning in patients with schizophrenia and schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The investigators propose a single dose, double-blinded, placebo-controlled trial of intranasal insulin in 40 subjects with schizophrenia or schizoaffective disorder to examine insulin's effect on cognition. The specific aims include:

  1. Examine the effects of single doses of 40 IU intranasal insulin compared to placebo on cognitive functioning, including attention and memory.
  2. Examine whether single dose of intranasal insulin administration will raise serum insulin level and decrease plasma glucose level

Insulin will be delivered through an air spray pump into your nose. The investigators will be comparing one dose of insulin (40 International Units) with placebo, an inactive liquid.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Insulin signaling in the brain is associated with improved cognitive function in both animal and human studies. Intranasal administration of insulin, which is non-invasive and minimizes the risk of hypoglycemia, may represent a new intervention approach with the potential to improve cognition and real life functioning in this patient with schizophrenia.

研究の種類

介入

入学 (実際)

30

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

  • アメリカ
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • Freedom Trail Clinic

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

18年～65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Age 18-65 years
  • Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype
  • Male or female
  • Stable dose of the current antipsychotic drug for at least one month
  • Well established compliance with out-patient treatment per treating clinician's judgement.
  • Able to complete the cognitive assessment battery (must be English speaking)

Exclusion Criteria:

  • Inability to provide informed consent
  • Current substance abuse
  • On clozapine or olanzapine
  • Psychiatrically unstable per treating clinician's judgement.
  • Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases etc.
  • Incapable to complete the cognitive battery assessment.

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

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：Placebo (1)
Subjects are given a one-time, single dose of placebo intranasal spray
薬：プラセボ
プラセボ
実験的：Single-Dose Intranasal Insulin
Subjects are given a one-time, single dose of intranasal insulin
薬：Insulin (Humulin)
40 IU Intranasal Insulin will be administered once
他の名前：
  • フムリン

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
メジャーの説明
時間枠
Improvement in Cognitive Function- HVLT Immediate Recall Total (Number)
時間枠：pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
Subjects performed the HVLT Immediate Recall Task. For this task, participants were read aloud a list of 12 words from three taxonomic categories. Participants were read the list three separate times, and after each reading were immediately asked to recall as many words from the list as they could. The number of words recalled successfully was measured before and after intranasal treatment. Values below represent posttreatment performance minus pretreatment performance.
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
Improvement in Cognitive Function- HVLT-Delayed Recall (Number)
時間枠：pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
Subjects performed the HVLT word recall task after a 20-minute delay before and after intranasal treatment. In the HVLT delayed recall task, participants were asked to recall the same list of 12 words dictated in the immediate recall task 20 minutes after the completion of the immediate recall task. Words successfully recalled after the 20-minute delay were measured. Values below represent posttreatment performance minus pretreatment performance.
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
CPT d Score
時間枠：pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
Subjects performed a computer-based test designed to measure sustained attention (attention to a specific stimuli over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The "d prime score" is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance.
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
Improvement in Cognitive Function- CPT Hits Rate (Proportion)
時間枠：pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in the previous outcome measure ("CPT d score"). Hits rate refers to each participant's ability to correctly respond to two consecutive target presentations (i.e. correct responses). Hits rate was measured as a proportion of overall attempts (0= no hits, 1.0= 100% accuracy on hits). Values below represent posttreatment performance minus pretreatment performance.
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds)
時間枠：pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure ("CPT d score"). Reaction time of hits refers to the average time each participant took to correctly respond to a stimuli in milliseconds. Values below represent posttreatment performance minus pretreatment performance.
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
Improvement in Cognitive Function- CPT False Alarm Rate (Proportion)
時間枠：pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure ("CPT d score"). False alarm rate refers to the proportion of overall attempts that were characterized as incorrect responses (responses to two non-identical targets). Values below represent posttreatment performance minus pretreatment performance.
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration

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

University of Massachusetts, Worcester

捜査官

  • 主任研究者：Xiaoduo Fan, MD, MPH, MS、UMass Medical School

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

2006年10月1日

一次修了 (実際)

2010年1月1日

研究の完了 (実際)

2010年1月1日

試験登録日

最初に提出

2008年1月31日

QC基準を満たした最初の提出物

2008年3月27日

最初の投稿 (見積もり)

2008年3月28日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年2月15日

QC基準を満たした最後の更新が送信されました

2013年2月12日

最終確認日

2013年2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

  • 4-2006
  • CORRC tracking number: 4-2006

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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