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Effect of Single Dose Intranasal Insulin On Cognitive Function

12 février 2013 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02114
        • Freedom Trail Clinic

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo (1)
Subjects are given a one-time, single dose of placebo intranasal spray
Médicament: Placebo
Placebo
Expérimental: Single-Dose Intranasal Insulin
Subjects are given a one-time, single dose of intranasal insulin
Médicament: Insulin (Humulin)
40 IU Intranasal Insulin will be administered once
Autres noms:
  • Humuline

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Improvement in Cognitive Function- HVLT Immediate Recall Total (Number)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Massachusetts, Worcester

Les enquêteurs

  • Chercheur principal: Xiaoduo Fan, MD, MPH, MS, UMass Medical School

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2006

Achèvement primaire (Réel)

1 janvier 2010

Achèvement de l'étude (Réel)

1 janvier 2010

Dates d'inscription aux études

Première soumission

31 janvier 2008

Première soumission répondant aux critères de contrôle qualité

27 mars 2008

Première publication (Estimation)

28 mars 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

15 février 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 février 2013

Dernière vérification

1 février 2013

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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