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- Registre américain des essais cliniques
- Essai clinique NCT00575666
Intranasal Insulin Treatment in Patients With Schizophrenia
15 novembre 2012 mis à jour par: Xiaoduo Fan, University of Massachusetts, Worcester
This study is an 8-week, randomized, double-blind, placebo-controlled trial of intranasal insulin as an adjunctive therapy, with a 4-week follow-up, in 60 non-diabetic schizophrenia subjects to examine insulin's effect on psychopathology and cognition.
In addition, the study will examine insulin's effects on weight, food intake, resting energy expenditure, and body composition.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The specific aims include:
Primary aims
- Examine the efficacy of intranasal regular insulin (40 IU 4 times per day) in improving cognitive deficits in patients with schizophrenia.
- Examine the efficacy of intranasal regular insulin in improving negative symptoms and positive symptoms of schizophrenia.
Secondary aims
- Examine intranasal insulin's effects on weight, food intake and resting energy expenditure.
- Examine intranasal insulin's effects on body composition, waist circumference, and waist/hip ratio.
Type d'étude
Interventionnel
Inscription (Réel)
45
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
-
-
Massachusetts
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Worcester, Massachusetts, États-Unis, 01605
- University of Massachusetts Medical School
-
-
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
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Age 18-65 years.
- Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype.
- Stable dose of the current antipsychotic drug for at least one month.
- Well established compliance with outpatient treatment per treating clinician's judgement.
- Able to complete the cognitive assessment battery (must be English speaking).
- Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study.
Exclusion Criteria:
- Inability to provide informed consent.
- Current substance abuse.
- Psychiatrically unstable per treating clinician's judgement.
- Significant medical illnesses including uncontrolled hypertension, diabetes, seizure. disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases.
- Pregnancy or breastfeeding.
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: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: B
Médicament : Placebo
|
intranasal, 40IU, 4 times daily
|
Expérimental: A
Intranasal Insulin Treatment
|
intranasal, 40IU, 4 times daily
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Cognitive Function- Digit Span Total
Délai: Week 8
|
Subjects completed the digit span task.
Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology.
Min score= 0, Max score= 30.
Week 8 values are displayed below.
|
Week 8
|
Cognitive Function- Verbal Fluency
Délai: Week 8
|
Subjects completed a verbal fluency test.
Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher levels of verbal fluency, and therefore less advanced psychopathology.
Min score= 0, Max score= N/A.
Week 8 values are displayed below.
|
Week 8
|
Cognitive Function- HVLT Immediate Recall Total
Délai: Week 8
|
Subjects completed a word recall task.
Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology.
Min score= 0, Max score= 36.
Week 8 values are displayed below.
|
Week 8
|
Cognitive Function- HVLT Delayed Recall Total
Délai: Week 8
|
Subjects completed a delayed word recall task.
Assessments were completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology.
Min score= 0, Max score= 12. Week 8 values are displayed below.
|
Week 8
|
Cognitive Function- Trails A
Délai: Week 8
|
Subjects completed a timed "trails" (i.e.
connect-the-dots) test.
Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were measured by time to complete in seconds.
Max score= N/A.
Lower values represent less advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
Cognitive Function- Trails B
Délai: Week 8
|
Subjects completed a timed "trails" (i.e.
connect the dots) test.
Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were mesured by time to complete in seconds.
Max score= N/A.
Lower values represent less advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
Cognitive Function- CPT D Prime Score
Délai: Week 8
|
Subjects completed a computer-based cognitive test designed to measure sustained attention (attention to a specific stimulus 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.
Higher scores represent less advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
Cognitive Function- CPT Hits Rate (Proportion)
Délai: Week 8
|
Subjects completed a computer-based cognitive test.
The test is described in detail in a previous outcome measure ("CPT d prime score").
Hits rate was defined as the proportion of correct responses to the relevant stimuli (response to two identical targets) compared to total responses (total hits).
Assessments were completed at Screening/Baseline, Week 4, and Week 8. Hits rate as a proportion of total hits was measured.
Min score= 0, Max score= 1.0.
Higher values represent higher stimulus recognition accuracy, and thus less advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
Cognitive Function- CPT Reaction Time of Hits (Milliseconds)
Délai: Week 8
|
Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes).
The test is described in detail in a previous outcome measure ("CPT d prime score").
Reaction time of hits is defined as the average time each participant took to respond correctly to relevant stimuli.
Assessments were completed at Screening/Baseline, Week 4, and Week 8. Reaction time was measured in milliseconds.
Max score= N/A.
Lower values represent less advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
Cognitive Function- CPT False-alarm Rate (Proportion)
Délai: Week 8
|
Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes).
False alarm rate is defined as the proportion of overall hits that were in response to an incorrect stimulus (two consecutive non-identical targets).
Assessments were completed at Screening/Baseline, Week 4, and Week 8. False-alarm hits were measured as a proportion of total hits.
Min score= 0, Max score= 1.0.
Lower values represent higher hit accuracy and less advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
Psychopathology- PANSS Total
Délai: Week 8
|
Positive symptoms, negative symptoms, and general psychopatholgy of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8.
The assessment consisted of 30 total items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme).
Min score= 30, Max score= 210.
Higher scores represent more advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
Psychopathology- PANSS Positive
Délai: Week 8
|
Positive symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8.
The assessment consisted of seven items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme).
Min score= 7, Max score= 49.
Higher scores represent more advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
Psychopathology- PANSS Negative
Délai: Week 8
|
Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of seven-items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme).
Min score= 7, Max score= 49.
Higher scores represent more advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
Psychopathology- PANSS General Psychopathology
Délai: Week 8
|
General psychopathology was measured at Screening/Baseline, Week 4, and Week 8.
The assessment consisted of 16 items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme).
Min score= 16, Max score= 112.
Higher scores represent more advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
Psychopathology- SANS Total
Délai: Week 8
|
Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 25 items, with each item measured on a six-point scale (0= none, 3= moderate, 5= severe).
Min score= 0, Max score= 125.
Higher scores represent more advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
Psychopathology- CDSS Total
Délai: Week 8
|
Symptoms of depression were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 9 items, with each item measured on a four-point scale (0= absent, 3= severe).
Min score= 0, Max score= 27.
Higher scores represent more advanced psychopathology.
Week 8 values are displayed below.
|
Week 8
|
Psychopathology- QLS Total
Délai: Week 8
|
Quality of life was measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 21 items, with each item measured on a seven-point scale (0= not present, 3= sometimes present, 6= always present).
Min score= 0, Max score= 126.
Higher scores represent lower quality of life.
Week 8 values are displayed below.
|
Week 8
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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 décembre 2007
Achèvement primaire (Réel)
1 septembre 2010
Achèvement de l'étude (Réel)
1 septembre 2010
Dates d'inscription aux études
Première soumission
14 décembre 2007
Première soumission répondant aux critères de contrôle qualité
14 décembre 2007
Première publication (Estimation)
18 décembre 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
17 décembre 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 novembre 2012
Dernière vérification
1 novembre 2012
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2007-P-000731
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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