- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00825539
Pharmacodynamic/Pharmacokinetic Study of AQW051 in Schizophrenia
A Single-dose, Placebo-controlled, Stratified, Randomized, Double-blind, Crossover to Study Pharmacodynamic Effects of AQW051 Followed by a 4-week Multiple-dose Safety and Tolerability in People With Chronic Stable Schizophrenia.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90073
- West LA VA Healthcare Center (UCLA)
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Department of Psychiatry & Behavioural Sciences, Feinberg School of Medicine (Northwestern University)
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Maryland
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Baltimore, Maryland, États-Unis, 21228
- Maryland Psychiatric Research Centre, Spring Grove Hospital Grounds
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Massachusetts General Hospital (Freedom Trail Clinic)
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Missouri
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Saint Louis, Missouri, États-Unis, 63110
- Washington University
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New York
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New York, New York, États-Unis, 10032
- Columbia University
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North Carolina
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Butner, North Carolina, États-Unis, 27509
- JUH Clinical Research (Duke University),
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV/DSM IV TR)
- Subjects will be currently treated with the stable regimen of one or more of the following second generation antipsychotics: olanzapine, risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
Subjects will meet the following symptom criteria:
- Brief Psychiatric Rating Scale (BPRS) Hallucinatory Behavior or Unusual Thought Content item scores less than or equal to 5
- BPRS Conceptual Disorganization item score less than or equal to 4
- Simpson-Angus Scale (SAS) total score less than or equal to 6
- Calgary Depression Scale (CDS) total score less than or equal to 10
Subjects will meet the following cognitive performance criteria:
- Maximum performance level: Performance below 1.0 SD from perfect performance on the Hopkins Verbal Learning Test (HVLT) total (31 or less),
- Minimum performance level: subject must be able to validly complete the fMRI cognitive paradigms
- WTAR: 5th grade reading level assessment
- Subjects must be symptomatically stable and not suffer from an acute exacerbation of their psychosis
Female subjects of childbearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study, through study completion. Pregnancy tests are required of all female subjects regardless of reported sterilization.
When performed at screening and practice visit, the result of this test must be received before the subject may be dosed.
- Male subjects must be using two acceptable methods of contraception, (e.g., spermicidal gel plus condom) for the entire duration of the studyuntil the Study Completion visit.
- Subject must have sufficiently stable overall health, as determined by the Investigator. The regular intake of concomitant drugs will be allowed, if the patient is on stable treatment for at least 3 months prior to study enrollment and the concomitant drug does not belong to the list of medication that are not allowed according to Appendix 3. If the patient takes more than one concomitant medication, it is at the Investigator's discretion to decide about the patient's eligibility, depending on the nature of the concomitant medications and the patient's overall health.
Exclusion criteria:
- Current treatment with conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine
- Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system
- Subjects with a DSM-IV diagnosis of substance abuse (other than nicotine) within the last month.
Subjects with a history of significant head injury/trauma, as defined by:
- Loss of consciousness (LOC) for more than 1 hour
- Recurring seizures resulting from the head injury
- Clear cognitive sequelae of the injury
- Cognitive rehabilitation following the injury
- Subjects with a medical or neurological disorder or treatment for such disorder that could interfere with the study medication of the assessment of the subject
- Use of certain concomitant medication
No grapefruit or grapefruit juice is to be consumed for 14 days prior to dosing until 7 days following the last dose.
Other protocol-defined inclusion/exclusion criteria may apply
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo
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Expérimental: AQW051
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Part 1: Assess BOLD response in key brain areas in schizophrenia patients during the performance of tasks as measured by (fMRI) in people with schizophrenia.
Délai: 2 years (Part 1: 1 year)
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2 years (Part 1: 1 year)
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Part 2: Assess safety and tolerability of multiple doses of AQW051 schizophrenia patients.
Délai: Part 2: 8 months
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Part 2: 8 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Measure: To assess the effects of a single dose of AQW051 on performance of working and episodic memory tasks in people with schizophrenia. (Part 1)
Délai: Time Frame: 2 years (Part 1: 1 year; Part 2: 8 months)
|
Time Frame: 2 years (Part 1: 1 year; Part 2: 8 months)
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Measure: To determine the relationship of exposure to brain activation after a single dose of AQW051 in people with schizophrenia. (Part 1)
Délai: 2 years (Part 1: 1 year; Part 2: 8 months)
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2 years (Part 1: 1 year; Part 2: 8 months)
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Measure: To determine the dose-exposure response relationship of multiple doses of AQW051 in people with schizophrenia. (Part 2)
Délai: 2 years (Part 1: 1 year; Part 2: 8 months)
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2 years (Part 1: 1 year; Part 2: 8 months)
|
Measure: To explore effects of multiple doses of AQW051 on measures of cognition in people with schizophrenia. (Part 2)
Délai: 2 years (Part 1: 1 year; Part 2: 8 months)
|
2 years (Part 1: 1 year; Part 2: 8 months)
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CAQW051A2202
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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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